NCT05404542

To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function

A Phase 1 Open-label Trial to Evaluate the Pharmacokinetics and Safety Following Single Dose of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Cerevel Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Tavapadon	Oral tablets

Timeline

• Start date: 2022-05-10
• Primary completion: 2023-08-14
• Completion: 2023-08-14
• First posted: 2022-06-03
• Last updated: 2024-04-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study