Trials / Completed
CompletedNCT04241393
An Open-label Trial to Evaluate Mass Balance of Tavapadon at Steady State in Healthy Subjects
An Open-label Trial to Evaluate the Absorption, Metabolism, and Excretion of a Single Dose of [14C]-Tavapadon in Healthy Adult Male Subjects at Steady State
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Cerevel Therapeutics, LLC · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this trial is to determine the absorption, metabolism, and excretion (AME) of \[14C\] tavapadon.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tavapadon tablet | Participants will receive multiple dose titration of Tavapadon (0.25 mg once daily \[QD\] on Days 1 to 3, 0.5 mg QD on Days 4 to 6, 1.0 mg QD on Days 7 to 9, 1.5 mg QD on Days 10 to 12, and 2.5 mg QD on Days 13 to 15) |
| DRUG | Tavapadon [14C] suspension | Following 15-Day multiple dose titration of Tavapadon, participants will receive a single oral dose of Tavapadon 2.5 mg containing approximately 100 μCi of \[14C\] Tavapadon on Day 16 |
Timeline
- Start date
- 2020-02-04
- Primary completion
- 2020-11-08
- Completion
- 2020-11-08
- First posted
- 2020-01-27
- Last updated
- 2020-11-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04241393. Inclusion in this directory is not an endorsement.