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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 is a Phase 1 study that has completed, run by Cerevel Therapeutics. The registered enrollment target is 16 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05106309
The ClinicalTrials.gov registry entry for NCT05106309 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cerevel Therapeutics, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which 10 mg CVL-231 as IR formulation is the first listed.
NCT05106309 reports 0 study locations.
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.
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