Pharmacokinetics of Cotadutide in Participants with Hepatic Impairment

Study identifier:D5671C00008

ClinicalTrials.gov identifier:NCT05517226

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Phase I, Parallel-group, Multi-center, Open-label, Investigation of the Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Injection of Cotadutide in Participants with Mild, Moderate or Severe Hepatic Impairment Compared to Participants with Normal Hepatic Function

Medical condition

Hepatic Impairment

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Cotadutide

Sex

All

Actual Enrollment

24

Study type

Interventional

Age

18 Years - 85 Years

Date

Study Start Date: 06 Sept 2022
Primary Completion Date: 27 Feb 2023
Study Completion Date: 27 Feb 2023

Study design

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

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria