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

Registration

Registration

NCT05517226

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

TERMINATED

Enrollment

24

Start

2022-09-06

Primary completion

2023-02-27

Lead sponsor

AstraZeneca

Conditions

Hepatic Impairment

Interventions

COMBINATION_PRODUCT:Cotadutide

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Maximum observed plasma (peak) drug concentration [Cmax] [Day 1 to Day 3]
• Area under plasma concentration time curve from zero to infinity (AUCinf) [Day 1 to Day 3]
• Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast) [Day 1 to Day 3]
• Time to reach peak or maximum observed concentration or response following drug administration (tmax) [Day 1 to Day 3]
• Terminal half-life (t½λz) [Day 1 to Day 3]
• Apparent total body clearance (CL/F) [Day 1 to Day 3]
• Apparent volume of distribution based on the terminal phase (Vz/F) [Day 1 to Day 3]