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An Open-label Trial to Evaluate Mass Balance of Tavapadon at Steady State in Healthy Subjects

NCT04241393 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-11-17

No results posted yet for this study

Summary

The purpose of this trial is to determine the absorption, metabolism, and excretion (AME) of \[14C\] tavapadon.

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

  • Cerevel Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Matthew Leoni, MD · Cerevel Therapeutics, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2020-11-08
Completion
2020-11-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04241393 on ClinicalTrials.gov