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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Participants will receive cotadutide subcutaneously.
Research Site
Hialeah, Florida, United States
Research Site
San Antonio, Texas, United States
Research Site
San Antonio, Texas, United States
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.
Time frame: Day 1 to Day 3
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.
Time frame: Day 1 to Day 3
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.
Time frame: Day 1 to Day 3
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.
Time frame: Day 1 to Day 3
Terminal half-life (t½λz)
The t½λz 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.
Time frame: Day 1 to Day 3
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.
Time frame: Day 1 to Day 3
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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.
Time frame: Day 1 to Day 3
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.
Time frame: From time of first dose to the final follow-up visit (Day 29)
Incidence of ADAs (anti-drug antibodies)
The safety, and tolerability of a single dose of cotadutide in participants with hepatic impairment will be assessed.
Time frame: From time of first dose to the final follow-up visit (Day 29)