NCT04295642

A 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease

A 2-Part, Open Label, Adaptive, Single and/or Multiple Oral Dose, Safety, Tolerability, and Food Effect Trial of CVL-751 in Subjects With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cerevel Therapeutics, LLC · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial will be a 2-part, adaptive, open label, single and/or multiple oral dose, safety, tolerability, food effect trial of CVL-751 in subjects with Parkinson's disease. Part 1 is a placebo-controlled, single dose cohort intended for assessment of safety and tolerability. In case of intolerable AEs, Part 2 would proceed as a multiple dose titration trial to achieve a 15 mg once daily dose while maintaining L-Dopa treatment (Part 2A). In case of a favorable tolerability profile in Part 1, Part 2B would proceed as a single dose trial (similar to Part 1), with discontinuation of L-Dopa for 24 hours (12 hours pre-Day 1 dose and 12 hours post-Day 1 dose).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	CVL-751	Oral tablet

Timeline

• Start date: 2020-01-08
• Primary completion: 2021-07-23
• Completion: 2021-07-23
• First posted: 2020-03-04
• Last updated: 2021-08-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study