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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05517226
Other study ID # D5671C00008
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date September 6, 2022
Est. completion date February 27, 2023

Study information

Verified date March 2023
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


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Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Cotadutide
Participants will receive cotadutide subcutaneously.

Locations

Country Name City State
United States Research Site Hialeah Florida
United States Research Site San Antonio Texas
United States Research Site San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum observed plasma (peak) drug concentration [Cmax] The Cmax of a single dose of cotadutide in participants with mild, moderate, or severe hepatic impairment compared to those with normal hepatic function will be assessed. Day 1 to Day 3
Primary Area under plasma concentration time curve from zero to infinity (AUCinf) The AUCinf of a single dose of cotadutide in participants with mild, moderate, or severe hepatic impairment compared to those with normal hepatic function will be assessed. Day 1 to Day 3
Primary Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast) The AUClast of a single dose of cotadutide in participants with mild, moderate, or severe hepatic impairment compared to those with normal hepatic function will be assessed. Day 1 to Day 3
Primary Time to reach peak or maximum observed concentration or response following drug administration (tmax) The tmax of a single dose of cotadutide in participants with mild, moderate, or severe hepatic impairment compared to those with normal hepatic function will be assessed. Day 1 to Day 3
Primary Terminal half-life (t½?z) The t½?z of a single dose of cotadutide in participants with mild, moderate, or severe hepatic impairment compared to those with normal hepatic function will be assessed. Day 1 to Day 3
Primary Apparent total body clearance (CL/F) The CL/F of a single dose of cotadutide in participants with mild, moderate, or severe hepatic impairment compared to those with normal hepatic function will be assessed. Day 1 to Day 3
Primary Apparent volume of distribution based on the terminal phase (Vz/F) The Vz/F of a single dose of cotadutide in participants with mild, moderate, or severe hepatic impairment compared to those with normal hepatic function will be assessed. Day 1 to Day 3
Secondary Number of participants with Adverse Events (AEs) The safety, and tolerability of a single dose of cotadutide in participants with hepatic impairment will be assessed. From time of first dose to the final follow-up visit (Day 29)
Secondary Incidence of ADAs (anti-drug antibodies) The safety, and tolerability of a single dose of cotadutide in participants with hepatic impairment will be assessed. From time of first dose to the final follow-up visit (Day 29)
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