To Evaluate the Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
NCT05404529 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2023-05-30
Summary
The primary purpose of the study is to assess the effect of hepatic impairment on the PK of tavapadon following administration of a single oral dose in participants with mild and moderate hepatic impairment relative to age, body weight, and sex-matched participants with normal hepatic function.
Conditions
- Hepatic Impairment
Interventions
- DRUG
-
Tavapadon
Oral tablets
Sponsors & Collaborators
-
Cerevel Therapeutics, LLC
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-04-29
- Primary Completion
- 2023-01-24
- Completion
- 2023-01-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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