Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234

Study identifier:D8750C00007

ClinicalTrials.gov identifier:NCT06845813

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234

Medical condition

Renal Impairment

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD6234

Sex

All

Estimated Enrollment

100

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 24 Feb 2025

Estimated Primary Completion Date: 02 Oct 2025

Estimated Study Completion Date: 02 Oct 2025

Study design

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

Verification:

Verified 01 Mar 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Participant must be 18 to 85 years of age, inclusive, at the time of signing the informed consent.
- Body weight ≥ 50 kg; BMI within the range of ≥ 18 to ≤ 40 kg/m2, as measured at screening.
Healthy Matched Control Participants:
- Participant must be medically healthy with no clinically significant medical history, or abnormalities in physical examination, clinical laboratory profiles, vital signs, or 12-lead ECGs, as deemed by the investigator at screening and Day -1.
- Have an eGFR of ≥ 90 mL/min determined at screening.
Renally-impaired Participants:
- Diagnosis of chronic kidney disease, stable renal function in the 3 months prior to dosing,
- Participants with renal impairment based on BSA-adjusted CKD-EPI equation at screening.
- All renally-impaired participants should be on a stable dose of cardio-renal relevant treatment for at least 2 weeks prior to screening.
- If participants with renal impairment have diabetes mellitus, it must be controlled
- Female(s) of childbearing potential: must use adequate contraception. Oral contraceptives are not permitted as there is a potential effect of the IMP on the absorption of oral drugs.
- Male Participants: Condom use is required for the duration of the study and until at least 28 days after the last dose of IMP. Additional contraception must be used for the sexual partners of male study participants throughout the clinical trial and for 28 days following the last dose of IMP.

Exclusion Criteria

- History or presence of:
significant GI disease or previous upper GI surgery
- Clinically significant cardiovascular disease, as judged by the investigator,
d. Neuromuscular or neurogenic disease
e. Severe vitamin D deficiency < 12 ng/dL.
- History or presence of any condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- History of psychosis, bipolar disorder
- History of major depressive disorder within the past 2 years
- History of suicide attempt or history of suicidal ideation within the past year.
Healthy Matched Control Participants:
- 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.
- Use of any prescription or non-prescription drugs, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
Renally-impaired Participants:
- Presence of unstable medical condition or any evidence of additional severe or uncontrolled systemic disease or laboratory finding which, in the opinion of the investigator, would compromise the participant’s safety or successful participation in this study.
- Renal transplant patients, participants waiting for organ transplant scheduled to occur during the study, and those with a history of acute kidney injury occurring within 3 months prior to screening. Nonfunctioning renal allografts are allowed.
- Use of concurrent medication which affects calculation of eGFR by affecting serum creatinine within 7 days of Day -1.
- Unable to refrain from phosphate binders, cholestyramine/colestipol, and ranitidine/nizatidine within 10 hours before and 10 hours after study intervention.

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No locations available

Arms	Assigned Interventions
Experimental: Group 1 Subjects with end stage renal disease will receive a single subcutaneous dose of AZD6234 under fasted conditions	Drug: AZD6234 Dose 1 Other Name: AZD6234 Other Name: Dose 1
Experimental: Group 2 Subjects with severe renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions	Drug: AZD6234 Dose 1 Other Name: AZD6234 Other Name: Dose 1
Experimental: Group 3 Healthy participants will receive a single subcutaneous dose of AZD6234 under fasted conditions	Drug: AZD6234 Dose 1 Other Name: AZD6234 Other Name: Dose 1
Experimental: Group 4 (optional) Subjects with moderate renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions	Drug: AZD6234 Dose 1 Other Name: AZD6234 Other Name: Dose 1
Experimental: Group 5 (optional) Subjects with mild renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions	Drug: AZD6234 Dose 1 Other Name: AZD6234 Other Name: Dose 1

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Fadi Saba

Site