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NCT04295642 · ClinicalTrials.gov registry record · Phase 1
A 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease
A Phase 1 study, sponsored by Cerevel Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04295642: Completed Phase 1 study, sponsored by Cerevel Therapeutics.
NCT04295642 is a Phase 1 study that has completed, run by Cerevel Therapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04295642, a Phase 1 study, has completed, sponsored by Cerevel Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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).
Primary Outcome
Peak Plasma Concentration (Cmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
Interventions
- DRUG CVL-751
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-01-08 |
| Est. Completion | 2021-07-23 |
| Phase | Phase 1 |
What the finished NCT04295642 record still lists
NCT04295642 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which CVL-751 is the first listed.
NCT04295642 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04295642 about?
NCT04295642 is a clinical study titled "A 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease". 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 ...
What is the current status of trial NCT04295642?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-01-08. Estimated completion is 2021-07-23.
What interventions are being tested in trial NCT04295642?
The interventions under investigation include: CVL-751 (DRUG).
Who is sponsoring clinical trial NCT04295642?
This trial is sponsored by Cerevel Therapeutics, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04295642's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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