Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone

Study identifier:D6402C00013

ClinicalTrials.gov identifier:NCT06388616

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

Hepatic Impairment

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Balcinrenone

Sex

All

Estimated Enrollment

28

Study type

Interventional

Age

18 Years - 79 Years

Date

Study Start Date: 02 May 2024
Estimated Primary Completion Date: 15 Nov 2024
Estimated Study Completion Date: 15 Nov 2024

Study design

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

Verification:

Verified 01 Jun 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria