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NCT05106309 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of CVL-231 Following Single Oral Administration of Modified- and Immediate-release Formulations in Fasted and Fed Healthy Participants
A Phase 1 study, sponsored by Cerevel Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT05106309: Completed Phase 1 study, sponsored by Cerevel Therapeutics.
NCT05106309 is a Phase 1 study that has completed, run by Cerevel Therapeutics. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05106309, a Phase 1 study, has completed, sponsored by Cerevel Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
A 2-part, crossover design, open-label treatment trial with 4 periods, 4 sequences (Part A) to evaluate MR formulations of CVL-231 and a 2 periods, 2 sequences (Part B) to understand effect of food on CVL-231 exposures from an MR formulation.
Interventions
- DRUG 10 mg CVL-231 as IR formulation
- DRUG 30 mg CVL-231 as slow-release MR formulation
- DRUG 30 mg CVL-231 as medium release MR formulation
- DRUG 30 mg CVL-231 as fast release MR formulation
- DRUG 30 mg CVL-231 Target Release, Fasted
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-12-29 |
| Est. Completion | 2022-02-24 |
| Phase | Phase 1 |
What the finished NCT05106309 record still lists
NCT05106309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 5 interventions - of which 10 mg CVL-231 as IR formulation is the first listed.
NCT05106309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05106309 about?
NCT05106309 is a clinical study titled "Pharmacokinetics of CVL-231 Following Single Oral Administration of Modified- and Immediate-release Formulations in Fasted and Fed Healthy Participants". A 2-part, crossover design, open-label treatment trial with 4 periods, 4 sequences (Part A) to evaluate MR formulations of CVL-231 and a 2 periods, 2 sequences (Part B) to understand effect of food on CVL-231 exposures from an MR formulation.
What is the current status of trial NCT05106309?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-12-29. Estimated completion is 2022-02-24.
What interventions are being tested in trial NCT05106309?
The interventions under investigation include: 10 mg CVL-231 as IR formulation (DRUG), 30 mg CVL-231 as slow-release MR formulation (DRUG), 30 mg CVL-231 as medium release MR formulation (DRUG), 30 mg CVL-231 as fast release MR formulation (DRUG), 30 mg CVL-231 Target Release, Fasted (DRUG).
Who is sponsoring clinical trial NCT05106309?
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 NCT05106309's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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