Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment
NCT05517226 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2023-03-21
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.
Conditions
- Hepatic Impairment
Interventions
- COMBINATION_PRODUCT
-
Cotadutide
Participants will receive cotadutide subcutaneously.
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-06
- Primary Completion
- 2023-02-27
- Completion
- 2023-02-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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