A study to assess the effect of AZD5055 on the pharmacokinetics (PK) of Nintedanib in healthy participants.

Study identifier:D8960C00003

ClinicalTrials.gov identifier:NCT05644600

EudraCT identifier:2022-003116-84

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

An Open Label, Randomised Study in Healthy Participants to Investigate the Effect of AZD5055 on the Pharmacokinetics of Nintedanib.

Medical condition

Healthy subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Nintedanib, AZD5055

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 26 May 2023

Primary Completion Date: 17 Jul 2023

Study Completion Date: 17 Jul 2023

Study design

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

Verification:

Verified 01 Sept 2024 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

Inclusion Criteria

1. Healthy nonsmoking male and female (of non-childbearing potential) participants aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
2. Females must have a negative pregnancy test, must not be lactating and must be of non childbearing potential.
3. Male participants and their woman partners of childbearing potential must be willing to use highly effective contraception measures and must refrain from donating sperm or fathering a child.

Exclusion Criteria

1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
2. History or presence of chronic gastrointestinal, hepatic, or renal disease, any acute disease in these organs, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
3. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP (Investigational Medicinal Product).
4. Untreated TB (Tuberculosis) or a positive result for the IGRA (Interferon Gamma Release Assay) (ie, QuantiFERON TB Gold).
5. Individuals with chronic infections (eg, urinary tract infection) or who are at increased risk of infection (eg, surgery, trauma, severe dental disease, or significant infection) .
6. History of severe COVID-19 (corona virus) infection requiring hospitalisation within the last 12 months prior to Screening, or clinical history compatible with Long COVID-19 (symptoms beyond 12 weeks of acute infection).
7. Has received live or live attenuated vaccine in the 30 days prior to dosing, the first dose of COVID-19 vaccine within 30 days prior to randomisation, or a COVID-19 vaccine second or booster vaccination within 10 days of Screening.
8. History of osteoporosis, osteomalacia, Paget's disease of the bone, thyrotoxicosis, rheumatoid arthritis, Cushing's disease, or a pathological fracture.
9. History of a traumatic fracture within 6 months of Screening.
10. Any laboratory values with the following deviations:
(1) Alanine aminotransferase > ULN
(2) Aspartate aminotransferase > ULN
(3) Total bilirubin > ULN
(4) White blood cell count < 3.5 × 109/L
(5) Platelet < LLN
(6) eGFR < 90 ml/min/1.73 m2 (Cockroft-Gault or CKD-EPI formula)
11. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (Electrocardiogram) and any clinically important abnormalities in the 12-lead ECG .
12. Any positive result on Screening for active hepatitis A, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or HIV antibody, or any known chronic/active liver diseases.
13. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5055 or nintedanib.
14. Use of any prescribed or non prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life.
15. Subjects who have previously received AZD5055.

Location

Research Site

Glendale, United Kingdom, 91206

Arms	Assigned Interventions
Experimental: Treatment A The subjects will receive Nintedanib soft capsules, fasted state.	Drug: Nintedanib The subjects will be administered Nintedanib soft capsules single oral dose in the morning of Day 1 in fasted state.
Experimental: Treatment B The subjects will receive dose B of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state.	Drug: Nintedanib The subjects will be administered Nintedanib soft capsules single oral dose in the morning of Day 1 in fasted state. Drug: AZD5055 The subjects will be administered AZD5055 as single oral dose on Day 1 in the fasted state.
Experimental: Treatment C The subjects will receive dose C of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state.	Drug: Nintedanib The subjects will be administered Nintedanib soft capsules single oral dose in the morning of Day 1 in fasted state. Drug: AZD5055 The subjects will be administered AZD5055 as single oral dose on Day 1 in the fasted state.
Experimental: Treatment D The subjects will receive dose C of the oral suspension of AZD5055 4 hours after nintedanib in the fasted state. Participants would remain in the fasted state until 1.5 hours after AZD5055 administration.	Drug: AZD5055 The subjects will be administered AZD5055 as single oral dose on Day 1 in the fasted state.

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted between 26 May 2023 to 17 July 2023 at Clinical unit in London

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The screening period was 28 days. Participants who met all the inclusion criteria were enrolled in the study. All the assessments were performed as per the schedule of the assessments.

Reporting Groups

	Description
Treatment sequence ABC	The subjects received treatment A: nintedanib soft capsules,fasted state; treatment B: dose B of AZD5055 oral suspension followed by nintedanib soft capsules, fasted state; treatment C: dose C of the AZD5055 oral suspension followed by nintedanib soft capsules, fasted state.
Treatment sequence BCA	The subjects received treatment B: dose B of AZD5055 oral suspension followed by nintedanib soft capsules, fasted state; treatment C: dose C of the AZD5055 oral suspension followed by nintedanib soft capsules, fasted state; treatment A: nintedanib soft capsules, fasted state.
Treatment sequence CAB	The subjects received treatment C: dose C of the AZD5055 oral suspension followed by nintedanib soft capsules, fasted state; treatment A: nintedanib soft capsules, fasted state; treatment B: dose B of AZD5055 oral suspension followed by nintedanib soft capsules, fasted state.

Participant Flow for 3 periods

Period 1: 1

	Treatment sequence ABC	Treatment sequence BCA	Treatment sequence CAB
STARTED	6	6	6
COMPLETED	6	6	6
NOT COMPLETED	0	0	0

Period 2: 2

	Treatment sequence ABC	Treatment sequence BCA	Treatment sequence CAB
STARTED	6	6	6
COMPLETED	6	6	6
NOT COMPLETED	0	0	0

Period 3: 3

	Treatment sequence ABC	Treatment sequence BCA	Treatment sequence CAB
STARTED	6	6	6
COMPLETED	6	6	6
NOT COMPLETED	0	0	0

Baseline Characteristics

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

The randomised set consisted of all participants randomised into the study.

Reporting Groups

	Description
Treatment sequence ABC	The subjects received treatment A: nintedanib soft capsules, fasted state; treatment B: dose B of AZD5055 oral suspension followed by nintedanib soft capsules, fasted state; treatment C: dose C of the AZD5055 oral suspension followed by nintedanib soft capsules, fasted state.
Treatment sequence BCA	The subjects received treatment B: dose B of AZD5055 oral suspension followed by nintedanib soft capsules, fasted state; treatment C: dose C of the AZD5055 oral suspension followed by nintedanib soft capsules, fasted state; treatment A: nintedanib soft capsules, fasted state.
Treatment sequence CAB	The subjects received treatment C: dose C of the AZD5055 oral suspension followed by nintedanib soft capsules, fasted state; treatment A: nintedanib soft capsules, fasted state; treatment B: dose B of AZD5055 oral suspension followed by nintedanib soft capsules, fasted state.

Baseline Measures

	Treatment sequence ABC	Treatment sequence BCA	Treatment sequence CAB	Total
Number of Participants [units: Participants]	6	6	6	18
Age Continuous [units: Years] Mean ± Standard Deviation	41.7 ± 8.4	32.0 ± 6.4	40.3 ± 7.6	38.0 ± 8.3
Sex: Female, Male [units: Participants]
Female	0	0	0	0
Male	6	6	6	18
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	0	0	0	0
Not Hispanic or Latino	6	6	6	18
Unknown or Not Reported	0	0	0	0
Race/Ethnicity, Customized [units: Participants] Race
White	5	4	5	14
Other	1	2	1	4

Outcome Measures

1. Primary Outcome Measure: Maximum observed plasma (peak) drug concentration (Cmax) of nintedanib [ Time Frame: Day 1 - 9 ]

Measure Type	Primary
Measure Name	Maximum observed plasma (peak) drug concentration (Cmax) of nintedanib
Measure Description	The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 was assessed.
Time Frame	Day 1 - 9
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 who received at least one dose of AZD5055 for whom at least 1 of the primary PK parameters for nintedanib could be calculated for at least 2 periods, and who had no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A	The subjects received nintedanib soft capsules, fasted state.
Treatment B	The subjects received dose B of the oral suspension of AZD5055 immediately followed by nintedanibin the fasted state.
Treatment C	The subjects received dose C of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state.

Measured Values

	Treatment A	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	18	18	18
Maximum observed plasma (peak) drug concentration (Cmax) of nintedanib [units: nanogram/milliliter (ng/mL)] Geometric Mean (Geometric Coefficient of Variation)	15.43 (44.06%)	15.54 (56.82%)	17.12 (39.16%)

Statistical Analysis 1 for Maximum observed plasma (peak) drug concentration (Cmax) of nintedanib

Groups^[1]	Treatment A, Treatment B
Other^[5]	1.0074
90% Confidence Interval	( 0.8633 to 1.1755 )

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

Statistical Analysis 2 for Maximum observed plasma (peak) drug concentration (Cmax) of nintedanib

Groups^[1]	Treatment A, Treatment C
Other^[5]	1.1094
90% Confidence Interval	( 0.9508 to 1.2946 )

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

2. Primary Outcome Measure: Area under plasma concentration time curve from zero to infinity (AUCinf) of nintedanib [ Time Frame: Day 1 - 9 ]

Measure Type	Primary
Measure Name	Area under plasma concentration time curve from zero to infinity (AUCinf) of nintedanib
Measure Description	The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 was assessed.
Time Frame	Day 1 - 9
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 who received at least one dose of AZD5055 for whom at least 1 of the primary PK parameters for nintedanib could be calculated for at least 2 periods, and who had no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A	The subjects received nintedanib soft capsules, fasted state.
Treatment B	The subjects received dose B of the oral suspension of AZD5055 immediately followed by nintedanibin the fasted state.
Treatment C	The subjects will receive dose C of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state.

Measured Values

	Treatment A	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	18	18	18
Area under plasma concentration time curve from zero to infinity (AUCinf) of nintedanib [units: hournanogram/Liter (hng/L)] Geometric Mean (Geometric Coefficient of Variation)	156.5 (42.47%)	148.9 (48.74%)	160.0 (30.80%)

Statistical Analysis 1 for Area under plasma concentration time curve from zero to infinity (AUCinf) of nintedanib

Groups^[1]	Treatment A, Treatment B
Other^[5]	0.9512
90% Confidence Interval	( 0.8345 to 1.0843 )

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

Statistical Analysis 2 for Area under plasma concentration time curve from zero to infinity (AUCinf) of nintedanib

Groups^[1]	Treatment A, Treatment C
Other^[5]	1.0219
90% Confidence Interval	( 0.8965 to 1.1648 )

[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. Primary Outcome Measure: Area under the plasma concentration time curve from zero to the last quantifiable concentration (AUClast) of nintedanib [ Time Frame: Day 1 - 9 ]

Measure Type	Primary
Measure Name	Area under the plasma concentration time curve from zero to the last quantifiable concentration (AUClast) of nintedanib
Measure Description	The effect of AZD5055 on the PK of nintedanib alone and in combination AZD5055 was assessed.
Time Frame	Day 1 - 9
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 who received at least one dose of AZD5055 for whom at least 1 of the primary PK parameters for nintedanib could be calculated for at least 2 periods, and who had no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment A	The subjects received nintedanib soft capsules, fasted state.
Treatment B	The subjects received dose B of the oral suspension of AZD5055 immediately followed by nintedanibin the fasted state.
Treatment C	The subjects received dose C of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state.

Measured Values

	Treatment A	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	18	18	18
Area under the plasma concentration time curve from zero to the last quantifiable concentration (AUClast) of nintedanib [units: hournanogram/millilitre (hng/mL)] Geometric Mean (Geometric Coefficient of Variation)	140.7 (43.27%)	134.1 (48.95%)	143.6 (31.57%)

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

Groups^[1]	Treatment A, Treatment B
Other^[5]	0.9525
90% Confidence Interval	( 0.8334 to 1.0886 )

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

Statistical Analysis 2 for Area under the plasma concentration time curve from zero to the last quantifiable concentration (AUClast) of nintedanib

Groups^[1]	Treatment A, Treatment C
Other^[5]	1.0206
90% Confidence Interval	( 0.8930 to 1.1664 )

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

4. Secondary Outcome Measure: Cmax of AZD5055 (Part A only) [ Time Frame: Day 1-9 ]

Measure Type	Secondary
Measure Name	Cmax of AZD5055 (Part A only)
Measure Description	The PK of AZD5055 after single Dose B or Dose C doses administered with a single oral dose of nintedanib was evaluated.
Time Frame	Day 1-9
Safety Issue?

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 who received at least one dose of AZD5055 for whom at least 1 of the primary PK parameters for nintedanib could be calculated for at least 2 periods, and who had no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment B	The subjects received dose B of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state.
Treatment C	The subjects received dose C of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.

Measured Values

	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	18	18
Cmax of AZD5055 (Part A only) [units: nanomol/Liter (nmol/L)] Geometric Mean (Geometric Coefficient of Variation)	108.8 (43.01%)	488.3 (37.19%)

No statistical analysis provided for Cmax of AZD5055 (Part A only)

5. Secondary Outcome Measure: AUCinf of AZD5055 (Part A only) [ Time Frame: Day 1-9 ]

Measure Type	Secondary
Measure Name	AUCinf of AZD5055 (Part A only)
Measure Description	The PK of AZD5055 after single Dose B or Dose C doses administered with a single oral dose of nintedanib was evaluated.
Time Frame	Day 1-9
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 who received at least one dose of AZD5055 for whom at least 1 of the primary PK parameters for nintedanib could be calculated for at least 2 periods, and who had no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment B	The subjects received dose B of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.
Treatment C	The subjects received dose C of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.

Measured Values

	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	18	18
AUCinf of AZD5055 (Part A only) [units: hourmole/Liter (hmol/L)] Geometric Mean (Geometric Coefficient of Variation)	846.0 (29.21%)	3204 (29.50%)

No statistical analysis provided for AUCinf of AZD5055 (Part A only)

6. Secondary Outcome Measure: AUClast of AZD5055 (Part A only) [ Time Frame: Day 1-9 ]

Measure Type	Secondary
Measure Name	AUClast of AZD5055 (Part A only)
Measure Description	The PK of AZD5055 after single Dose B or Dose C doses administered with a single oral dose of nintedanib was evaluated.
Time Frame	Day 1-9
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 who received at least one dose of AZD5055 for whom at least 1 of the primary PK parameters for nintedanib could be calculated for at least 2 periods, and who had no important protocol deviations thought to impact on the analysis of the PK data.

Reporting Groups

	Description
Treatment B	The subjects received dose B of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.
Treatment C	The subjects received dose C of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.

Measured Values

	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	18	18
AUClast of AZD5055 (Part A only) [units: hournanomole/Liter (hnmol/L)] Geometric Mean (Geometric Coefficient of Variation)	821.4 (29.62%)	3123 (29.72%)

No statistical analysis provided for AUClast of AZD5055 (Part A only)

7. Secondary Outcome Measure: Cmax of ninetedanib alone and in combination AZD5055 (Part B only) [ Time Frame: Day 1-6 ]

Measure Type	Secondary
Measure Name	Cmax of ninetedanib alone and in combination AZD5055 (Part B only)
Measure Description	The effect of AZD5055 on the PK of nintedanib when AZD5055 dose is staggered (delayed) 4 hours was assessed.
Time Frame	Day 1-6
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.
Sponsor have decided not to implement Part B in study design. Hence, no participants were analysed in Part B.

Reporting Groups

	Description
Treatment A	The subjects received Nintedanib soft capsules, fasted state.
Treatment B	The subjects received dose B of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.
Treatment C	The subjects received dose C of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.

Measured Values

	Treatment A	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	0	0	0
Cmax of ninetedanib alone and in combination AZD5055 (Part B only) [units: nanogram/milliliter (ng/mL)] Geometric Mean (Geometric Coefficient of Variation)

No statistical analysis provided for Cmax of ninetedanib alone and in combination AZD5055 (Part B only)

8. Secondary Outcome Measure: AUCinf of ninetedanib alone and in combination AZD5055 (Part B only) [ Time Frame: Day 1-6 ]

Measure Type	Secondary
Measure Name	AUCinf of ninetedanib alone and in combination AZD5055 (Part B only)
Measure Description	The effect of AZD5055 on the PK of nintedanib when AZD5055 dose is staggered (delayed) 4 hours was assessed.
Time Frame	Day 1-6
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.
Sponsor have decided not to implement Part B in study design. Hence, no participants were analysed in Part B.

Reporting Groups

	Description
Treatment A	The subjects received Nintedanib soft capsules, fasted state.
Treatment B	The subjects received dose B of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.
Treatment C	The subjects received dose C of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.

Measured Values

	Treatment A	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	0	0	0
AUCinf of ninetedanib alone and in combination AZD5055 (Part B only) [units: hournanogram/milliliter (hng/mL)] Geometric Mean (Geometric Coefficient of Variation)

No statistical analysis provided for AUCinf of ninetedanib alone and in combination AZD5055 (Part B only)

9. Secondary Outcome Measure: AUClast of ninetedanib alone and in combination AZD5055 (Part B only) [ Time Frame: Day 1-6 ]

Measure Type	Secondary
Measure Name	AUClast of ninetedanib alone and in combination AZD5055 (Part B only)
Measure Description	The effect of AZD5055 on the PK of nintedanib when AZD5055 dose was staggered (delayed) 4 hours is assessed.
Time Frame	Day 1-6
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.
Sponsor have decided not to implement Part B in study design. Hence, no participants were analysed in Part B.

Reporting Groups

	Description
Treatment A	The subjects received Nintedanib soft capsules, fasted state.
Treatment B	The subjects received dose B of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.
Treatment C	The subjects will receive dose C of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.

Measured Values

	Treatment A	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	0	0	0
AUClast of ninetedanib alone and in combination AZD5055 (Part B only) [units: hournanogram/milliliter (hng/mL)] Geometric Mean (Geometric Coefficient of Variation)

No statistical analysis provided for AUClast of ninetedanib alone and in combination AZD5055 (Part B only)

10. Secondary Outcome Measure: Number of subject with Adverse event (AE) and serious Adverse event (SAE) [ Time Frame: SAEs: From Screening (Day -28 to -2) to Day -1 of Period 1 AEs: From Day 1 until follow up (Day 13) ]

Measure Type	Secondary
Measure Name	Number of subject with Adverse event (AE) and serious Adverse event (SAE)
Measure Description	The safety and tolerability following single oral doses ofAZD5055 administered with nintedanib in healthy participants will be assessed.
Time Frame	SAEs: From Screening (Day -28 to -2) to Day -1 of Period 1 AEs: From Day 1 until follow up (Day 13)
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 safety analysis set included all participants who received at least 1 dose of AZD5055 and for whom any safety post-dose data are available.

Reporting Groups

	Description
Treatment A	The subjects received Nintedanib soft capsules, fasted state.
Treatment B	The subjects received dose B of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.
Treatment C	The subjects received dose C of the oral suspension ofAZD5055 immediately followed by nintedanib in the fasted state.

Measured Values

	Treatment A	Treatment B	Treatment C
Number of Participants Analyzed [units:participants]	18	18	18
Number of subject with Adverse event (AE) and serious Adverse event (SAE) [units: Participants]	6	8	6

No statistical analysis provided for Number of subject with Adverse event (AE) and serious Adverse event (SAE)

Serious Adverse Events

Time Frame	SAEs: From Screening (Day -28 to -2) to Day -1 of Period 1 AEs: From Day 1 until follow up (Day 13)
Additional Description	No text entered.

Reporting Groups

	Description
Treatment A	The subjects will receive Nintedanib soft capsules, fasted state.
Treatment B	The subjects will receive dose B of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state.
Treatment C	The subjects will receive dose C of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state.

Serious Adverse Events

	Treatment A	Treatment B	Treatment C
Total, serious adverse events
# participants affected / at risk	0/18 (0.00%)	0/18 (0.00%)	0/18 (0.00%)

Other Adverse Events

Time Frame	SAEs: From Screening (Day -28 to -2) to Day -1 of Period 1 AEs: From Day 1 until follow up (Day 13)
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Treatment A	The subjects will receive Nintedanib soft capsules, fasted state.
Treatment B	The subjects will receive dose B of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state.
Treatment C	The subjects will receive dose C of the oral suspension of AZD5055 immediately followed by nintedanib in the fasted state.

Other Adverse Events

Treatment A

Treatment B

Treatment C

Total, other (not including serious) adverse events