Study to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Inducer Carbamazepine on Tavapadon Pharmacokinetics in Healthy Adult Participants

Phase 1

Waitlist Available

Research Sponsored by Cerevel Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 31

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how a drug affects the body when taken with another drug to see if it is safe.

Eligible Conditions

Parkinson's Disease
Dementia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 31

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 31

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 31 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tavapadon Followed by Tavapadon + CarbamazepineExperimental Treatment2 Interventions

Participants will receive oral tavapadon tablets titrated up to a steady-state dose from Day 1 to Day 14. From Day 15, participants will receive oral carbamazepine tablets titrated up to a steady-state dose along with oral tavapadon tablets, up to Day 30.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tavapadon

2022

Completed Phase 3

~1420

Carbamazepine

2016

Completed Phase 4

~2690