A study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6615 in healthy subjects

Study identifier:D7991C00001

ClinicalTrials.gov identifier:NCT04055168

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase I Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 After Single Dosing to Healthy Subjects

Medical condition

Dyslipidemia

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD6615, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 60 Years

Date

Study Start Date: 24 Jul 2019

Primary Completion Date: 10 Feb 2020

Study Completion Date: 10 Feb 2020

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2021 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

1. Provision of signed and dated, written informed consent prior to any study specific procedures.
2. Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non-child-bearing potential.
3. Provision of signed, written and dated informed consent for optional genetic research.
4: In Part 1: Healthy male and/or female Non-Asian subjects aged 20 - 60 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture. In Part 2: Healthy male and/or female Japanese subjects aged 20 – 60 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture.
5. Have a body mass index between 18 and 30 kg/m^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at the Screening Visit and Day -1.
6. Males should avoid fathering a child by either true abstinence or a highly effective contraception form of birth control during the study.

Exclusion Criteria

1. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
2. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
3. Subjects with known autoimmune disease or on treatment with immune-modulatory drugs.
4. Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational medicinal product.
5. Any laboratory values with the following deviations at the Screening Visit and/or Day -1, test may be repeated once for each visit at the discretion of the Investigator if out of range: (Alanine aminotransferase > upper limit of normal [ULN], Aspartate aminotransferase > ULN, Creatinine > ULN, White blood cell count < 3.5 x 10^9/L, Hb < lower limit of normal [LLN], Platelet count
6. Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus.
7. Abnormal vital signs, any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-Lead ECG as considered by the Investigator, that may interfere with the interpretation of QTc interval changes.
8. Known or suspected history of drug abuse, current smoker or those who have smoked or used nicotine products within the previous 3 months before the Screening Visit.
9. History of alcohol abuse and/or severe allergy/hypersensitivity.
10. Previous bone marrow transplant.
11. Males who are unwilling to use an acceptable method of birth control during the entire study period.

Location

Research Site

Glendale, CA, United States, 91206

Location

Research Site

Baltimore, MD, United States, 21225

Location

Research Site

Glendale, CA, United States, 91206

Arms	Assigned Interventions
Experimental: Cohort 1 - Part 1 On Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 1 of AZD6615 (6 subjects) or matching placebo (2 subjects).	Drug: AZD6615 AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Study drug Drug: Placebo Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Control
Experimental: Cohort 2 - Part 1 On Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 2 of AZD6615 (6 subjects) or matching placebo (2 subjects).	Drug: AZD6615 AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Study drug Drug: Placebo Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Control
Experimental: Cohort 3 - Part 1 On Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 3 of AZD6615 (6 subjects) or matching placebo (2 subjects).	Drug: AZD6615 AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Study drug Drug: Placebo Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Control
Experimental: Cohort 1 - Part 2 On Day 1, randomized subjects (healthy Japanese subjects) will receive dose 1 of AZD6615 (6 subjects) or matching placebo (2 subjects).	Drug: AZD6615 AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Study drug Drug: Placebo Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Control
Experimental: Cohort 2 - Part 2 On Day 1, randomized subjects (healthy Japanese subjects) will receive dose 2 of AZD6615 (6 subjects) or matching placebo (2 subjects).	Drug: AZD6615 AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Study drug Drug: Placebo Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects. Other Name: Control

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted in 24 healthy male and female Non-Asian participants at Parexel Early Phase Clinical Unit – Los Angeles from 24 July 2019 (first participant consented – Part A) to 10 February 2020 (last participant last visit – Part A)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a Screening Period of maximum 28 days. All the study assessments were performed as per the schedule of assessment.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2)	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.
Pooled placebo	Randomized participants received a single oral dose of matching placebo.

Participant Flow: Overall Study

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2)	Cohort 3 - Part A1 (AZD6615 Dose 3)	Pooled placebo
STARTED	6	6	6	6
COMPLETED	6	6	6	6
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2)	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.
Pooled placebo	Randomized participants received a single oral dose of matching placebo.

Baseline Measures

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2)	Cohort 3 - Part A1 (AZD6615 Dose 3)	Pooled placebo	Total
Number of Participants [units: Participants]	6	6	6	6	24
Age Continuous [units: Years] Mean ± Standard Deviation
AZD6615	43.2 ± 16.8	32.0 ± 7.5	31.2 ± 14.2		35.4 ± 13.8
Pooled placebo				42.7 ± 7.3	42.7 ± 7.3
Sex: Female, Male [units: Participants]
Female	2	0	0	1	3
Male	4	6	6	5	21
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	2	3	3	1	9
White	4	3	2	4	13
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	1	1	2
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	2	2	1	3	8
Not Hispanic or Latino	4	4	5	3	16
Unknown or Not Reported	0	0	0	0	0

Outcome Measures

1. Primary Outcome Measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From screening until Final Follow-up/ early termination (ET) (Week 12 Post-dose) ]

Measure Type	Primary
Measure Name	Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measure Description	The safety and tolerability of AZD6615 following oral administration of single ascending doses was assessed in fasted participants.
Time Frame	From screening until Final Follow-up/ early termination (ET) (Week 12 Post-dose)
Safety Issue?	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Safety Analysis Set included all participants who received at least 1 dose of study drug including AZD6615 or placebo and for whom any safety post dose data were available.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.
Pooled placebo	Randomized participants received a single oral dose of matching placebo.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)	Pooled placebo
Number of Participants Analyzed [units:participants]	6	6	6	6
Number of participants with adverse events (AEs) and serious adverse events (SAEs) [units: Participants]
Any treatment-emergent adverse event (TEAE)	4	0	1	0
Any TEAE with outcome of death	0	0	0	0
Any TSAE (including events with outcome = death)	0	0	0	0
Any TEAE leading to discontinuation of the study drug	0	0	0	0
Any TEAE leading to withdrawal from the study	0	0	0	0
Any TEAE leading to dose interruption	0	0	0	0
Any TEAE leading to dose reduction	0	0	0	0

No statistical analysis provided for Number of participants with adverse events (AEs) and serious adverse events (SAEs)

2. Secondary Outcome Measure: Maximum observed concentration (Cmax) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Maximum observed concentration (Cmax) for AZD6615
Measure Description	The pharmacokinetic (PK) of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	6	6	6
Maximum observed concentration (Cmax) for AZD6615 [units: ng/mL] Geometric Mean (Geometric Coefficient of Variation)	0.9852 (195.0%)	1.099 (131.2%)	2.927 (196.8%)

Statistical Analysis 1 for Maximum observed concentration (Cmax) for AZD6615

Groups^[1]	All groups
Slope^[5]	0.9013
Standard Error of the mean	± 0.6104
90% Confidence Interval	( -0.1643 to 1.967 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

3. Secondary Outcome Measure: Time to reach maximum observed concentration (tmax) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Time to reach maximum observed concentration (tmax) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	6	6	6
Time to reach maximum observed concentration (tmax) for AZD6615 [units: Hour] Median (Full Range)	2.51 (1.50 to 4.02)	2.77 (2.00 to 8.00)	1.75 (1.48 to 3.00)

No statistical analysis provided for Time to reach maximum observed concentration (tmax) for AZD6615

4. Secondary Outcome Measure: Terminal half-life (t½λz) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Terminal half-life (t½λz) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	2	5	5
Terminal half-life (t½λz) for AZD6615 [units: Hour] Mean (Standard Deviation)	NA (NA)^[1]	3.115 (3.047)	9.649 (13.15)

No statistical analysis provided for Terminal half-life (t½λz) for AZD6615

5. Secondary Outcome Measure: Terminal elimination rate constant (λz) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Terminal elimination rate constant (λz) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	2	5	5
Terminal elimination rate constant (λz) for AZD6615 [units: 1/hour] Mean (Standard Deviation)	NA (NA)^[1]	0.5243 (0.4856)	0.2216 (0.1873)

No statistical analysis provided for Terminal elimination rate constant (λz) for AZD6615

6. Secondary Outcome Measure: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	6	5	6
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast) for AZD6615 [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation)	1.600 (187.2%)	3.880 (47.39%)	7.668 (130.5%)

Statistical Analysis 1 for Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast) for AZD6615

Groups^[1]	All groups
Slope^[5]	1.412
Standard Error of the mean	± 0.4908
90% Confidence Interval	( 0.5520 to 2.273 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

7. Secondary Outcome Measure: Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC0-24) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC0-24) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	2	5	5
Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC0-24) for AZD6615 [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation)	NA (NA%)^[1]	4.233 (41.82%)	9.735 (107.7%)

No statistical analysis provided for Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC0-24) for AZD6615

8. Secondary Outcome Measure: Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	2	5	5
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) for AZD6615 [units: h*ng/mL] Geometric Mean (Geometric Coefficient of Variation)	NA (NA%)^[1]	4.428 (40.25%)	10.19 (117.6%)

Statistical Analysis 1 for Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) for AZD6615

Groups^[1]	All groups
Slope^[5]	1.195
Standard Error of the mean	± 0.7493
90% Confidence Interval	( -0.1630 to 2.553 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[5]	Other relevant estimation information:
	No text entered.

9. Secondary Outcome Measure: Apparent volume of distribution (Vz/F) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Apparent volume of distribution (Vz/F) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	2	5	5
Apparent volume of distribution (Vz/F) for AZD6615 [units: Liter] Mean (Standard Deviation)	NA (NA)^[1]	43950 (41380)	45580 (20020)

No statistical analysis provided for Apparent volume of distribution (Vz/F) for AZD6615

10. Secondary Outcome Measure: Apparent total body clearance (CL/F) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Apparent total body clearance (CL/F) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	2	5	5
Apparent total body clearance (CL/F) for AZD6615 [units: Liter/hour] Mean (Standard Deviation)	NA (NA)^[1]	9543 (3255)	7962 (6098)

No statistical analysis provided for Apparent total body clearance (CL/F) for AZD6615

11. Secondary Outcome Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCinf/D) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCinf/D) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	2	5	5
Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCinf/D) for AZD6615 [units: h*ng/mL/mg] Geometric Mean (Geometric Coefficient of Variation)	NA (NA%)^[1]	0.1107 (40.25%)	0.1699 (117.6%)

No statistical analysis provided for Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCinf/D) for AZD6615

12. Secondary Outcome Measure: Area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered (AUC0-24/D) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered (AUC0-24/D) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	2	5	5
Area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered (AUC0-24/D) for AZD6615 [units: h*ng/mL/mg] Geometric Mean (Geometric Coefficient of Variation)	NA (NA%)^[1]	0.1058 (41.82%)	0.1622 (107.7%)

No statistical analysis provided for Area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered (AUC0-24/D) for AZD6615

13. Secondary Outcome Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	6	5	6
Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D) for AZD6615 [units: h*ng/mL/mg] Geometric Mean (Geometric Coefficient of Variation)	0.07999 (187.2%)	0.09701 (47.39%)	0.1278 (130.5%)

No statistical analysis provided for Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D) for AZD6615

14. Secondary Outcome Measure: Mean Residence Time from time 0 to infinity (MRT) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Mean Residence Time from time 0 to infinity (MRT) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data. Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	2	5	5
Mean Residence Time from time 0 to infinity (MRT) for AZD6615 [units: Hour] Geometric Mean (Geometric Coefficient of Variation)	NA (NA%)^[1]	6.338 (57.37%)	6.948 (48.03%)

No statistical analysis provided for Mean Residence Time from time 0 to infinity (MRT) for AZD6615

15. Secondary Outcome Measure: Observed maximum concentration divided by the dose administered (Cmax/D) for AZD6615 [ Time Frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose) ]

Measure Type	Secondary
Measure Name	Observed maximum concentration divided by the dose administered (Cmax/D) for AZD6615
Measure Description	The PK of AZD6615 was characterized after single oral dosing.
Time Frame	Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours post-dose, at 2, 4, 6, and 8 weeks post-dose, at Final Follow-up/ ET (Week 12 Post-dose)
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The PK Analysis Set consisted of all participants in the Safety Analysis Set who received AZD6615 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.

Measured Values

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2	Cohort 3 - Part A1 (AZD6615 Dose 3)
Number of Participants Analyzed [units:participants]	6	6	6
Observed maximum concentration divided by the dose administered (Cmax/D) for AZD6615 [units: ng/mL/mg] Geometric Mean (Geometric Coefficient of Variation)	0.04926 (195.0%)	0.02747 (131.2%)	0.04878 (196.8%)

No statistical analysis provided for Observed maximum concentration divided by the dose administered (Cmax/D) for AZD6615

Serious Adverse Events

Time Frame	From screening until Final Follow-up/ early termination (ET) (Week 12 Post-dose)
Additional Description	No text entered.

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2)	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.
Pooled placebo	Randomized participants received a single oral dose of matching placebo.

Serious Adverse Events

	Cohort 1 - Part A1 (AZD6615 Dose 1)	Cohort 2 - Part A1 (AZD6615 Dose 2)	Cohort 3 - Part A1 (AZD6615 Dose 3)	Pooled placebo
Total, serious adverse events
# participants affected / at risk	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)	0/6 (0.00%)

Other Adverse Events

Time Frame	From screening until Final Follow-up/ early termination (ET) (Week 12 Post-dose)
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Cohort 1 - Part A1 (AZD6615 Dose 1)	Randomized participants received a single oral dose of AZD6615.
Cohort 2 - Part A1 (AZD6615 Dose 2)	Randomized participants received a single oral dose of AZD6615.
Cohort 3 - Part A1 (AZD6615 Dose 3)	Randomized participants received a single oral dose of AZD6615.
Pooled placebo	Randomized participants received a single oral dose of matching placebo.

Other Adverse Events

Cohort 1 - Part A1 (AZD6615 Dose 1)

Cohort 2 - Part A1 (AZD6615 Dose 2)

Cohort 3 - Part A1 (AZD6615 Dose 3)

Pooled placebo

Total, other (not including serious) adverse events

# participants affected / at risk

4/6 (66.67%)

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

Ear and labyrinth disorders

Vertigo¹

# participants affected / at risk

1/6 (16.67%)

0/6 (0.00%)

Gastrointestinal disorders

Diarrhoea¹

# participants affected / at risk

1/6 (16.67%)

0/6 (0.00%)

Infections and infestations

Upper respiratory tract infection¹

# participants affected / at risk

3/6 (50.00%)

0/6 (0.00%)

Musculoskeletal and connective tissue disorders

Arthralgia¹

# participants affected / at risk

1/6 (16.67%)

0/6 (0.00%)

Nervous system disorders

Headache¹

# participants affected / at risk

1/6 (16.67%)

0/6 (0.00%)

Nervous system disorders

Presyncope¹

# participants affected / at risk

0/6 (0.00%)

1/6 (16.67%)

0/6 (0.00%)

Respiratory, thoracic and mediastinal disorders

Oropharyngeal pain¹

# participants affected / at risk

1/6 (16.67%)

0/6 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA version 22.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No unpublished information may be disclosed without prior written approval from AstraZeneca AB.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only part A of the study was conducted. Parts A2, B, and C of the study were cancelled by AstraZeneca following a request for additional animal data before initiating studies of longer duration.

Results Point of Contact

Name/Title:	Global Clinical Lead
Organization:	AstraZeneca Clinical Study Information Center
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

David Han

California Clinical Trials Medical Group

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Trial Results Summaries