A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants with Renal Impairment - GLITTER

Study identifier:D9090C00010

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:2024-514359-14-00

Will Be Recruiting

Official Title

A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants with Renal Impairment

Medical condition

Renal Impairment

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5462

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 13 Nov 2024

Estimated Primary Completion Date: 28 Apr 2025

Estimated Study Completion Date: 28 Apr 2025

Study design

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

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

Healthy matched participants (cohort2):
• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Stable renal function (eg, no clinically significant change in an eGFR within 3 months or longer prior to study screening), as determined by the investigator.
• An eGFR of ≥ 90 mL/min/1.73 m2, as determined at Screening Visit using the CKD-EPI 2021 creatinine only equation.
Participants With Renal Impairment:
• Participants with severe renal impairment (Cohort 1) must have an eGFR ≥ 15 to < 30 mL/min/1.73 m2, as determined at Screening Visit using the CKD-EPI 2021 creatinine only equation and not on dialysis.
• Participants with moderate renal impairment (Cohort 3) must have an eGFR of ≥ 30 to < 60 mL/min/1.73 m2, as determined at Screening Visit using the CKD-EPI 2021 creatinine only equation and not on dialysis.
• Stable renal impairment (eg, no clinically significant change in eGFR within 3 months or longer prior to study screening), for both Cohorts 1 and 3, as determined by the investigator.
• BMI within the range ≥ 18 to < 35 kg/m2, inclusive.
• Females of non-childbearing potential and males.
-
Main

Exclusion Criteria

• As judged by the investigator, any evidence of clinically significant disease or abnormal findings in screening assessments which in the investigator’s opinion makes it undesirable for the participant to participate in the study.
• Positive HCV Ab, HBsAg, or HBcAb, HIV at screening.
Healthy Matched Participants (Cohort 2):
• Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal including bone fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric, major physical impairment, or coagulation disorders) which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the result of the study, or the participant’s ability to participate in the study.
Participants With Renal Impairment:
• Presence of unstable medical (eg, diabetes) or psychological conditions which, in the opinion of the investigator, would compromise the participant’s safety or successful participation in this study.
• Renal transplant participants, participants on dialysis, and those with a history of acute kidney injury. Use of concurrent medication, which affects creatinine clearance such as cephalosporin antibiotics, ascorbic acid, trimethoprim, cimetidine, quinine within 7 days of Day –1.

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1 Participants with severe renal impairment (eGFR ≥ 15 to < 30 mL/min/1.73 m2, not requiring dialysis).	Drug: AZD5462 Participants will receive AZD5462 orally.
Experimental: Cohort 2 Participants who are healthy control (eGFR ≥ 90 mL/min/1.73 m2) matched at a group level to Cohort 1.	Drug: AZD5462 Participants will receive AZD5462 orally.
Experimental: Cohort 3 (conditional) Participants with moderate renal impairment (eGFR ≥ 30 to < 60 mL/min/1.73 m2).	Drug: AZD5462 Participants will receive AZD5462 orally.

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]