NCT05581823

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

A Phase 1, Open-label, Fixed-sequence, Crossover Trial to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Induction by Carbamazepine on the Steady-state Pharmacokinetics of Tavapadon in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Cerevel Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the effect of carbamazepine, a strong CYP3A4 inducer, on the steady-state pharmacokinetics (PK) of tavapadon in healthy adult participants.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Tavapadon	Oral tablets
DRUG	Carbamazepine	Extended-release oral tablets

Timeline

• Start date: 2022-10-19
• Primary completion: 2023-01-27
• Completion: 2023-02-02
• First posted: 2022-10-17
• Last updated: 2023-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study