To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function
NCT05404542 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2024-04-02
Summary
The primary purpose is to assess the effect of renal impairment on the PK of tavapadon following administration of a single oral dose in participants with severe renal impairment relative to age, body weight, and sex-matched participants with normal renal function.
Conditions
- Renal 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
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-05-10
- Primary Completion
- 2023-08-14
- Completion
- 2023-08-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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