NCT05517226

Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study will assess the pharmacokinetics (PK), 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.

Detailed description

This study will consist of four cohorts (Cohort 1, Cohort 2, Cohort 3, and Cohort 4). Participants will be assigned to each of the cohorts as per Child-Pugh classification: * Cohort 1: Mild hepatic impairment (Child-Pugh A), cotadutide 50 μg * Cohort 2: Moderate hepatic impairment (Child-Pugh B), cotadutide 50 μg * Cohort 3: Severe hepatic impairment (Child-Pugh C), cotadutide 50 μg * Cohort 4: Normal hepatic function, cotadutide 50 μg

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Cotadutide	Participants will receive cotadutide subcutaneously.

Timeline

• Start date: 2022-09-06
• Primary completion: 2023-02-27
• Completion: 2023-02-27
• First posted: 2022-08-26
• Last updated: 2023-03-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study