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NCT05965219 · ClinicalTrials.gov registry record · Phase 1
A Trial to Evaluate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of Emraclidine and of Emraclidine on the Pharmacokinetics of Metformin in Healthy Adult Participants
A Phase 1 study of Healthy Volunteers, sponsored by Cerevel Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05965219: Completed Phase 1 study of Healthy Volunteers, sponsored by Cerevel Therapeutics.
NCT05965219 is a Phase 1 study of Healthy Volunteers that has completed, run by Cerevel Therapeutics. The registered enrollment target is 60 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05965219, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Cerevel Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of the study is to evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of emraclidine and metabolite CV-0000364 in Part A, the effect of carbamazepine, a strong CYP3A4 inducer, on the PK of emraclidine and metabolite CV-0000364 in Part B, and to evaluate the effect of emraclidine on the PK of metformin in Part C in healthy adult participants.
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Emraclidine
- DRUG Itraconazole
- DRUG Carbamazepine
Study Locations (1)
Kansas
- Overland Park, Kansas - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2023-11-10 |
| Phase | Phase 1 |
What the finished NCT05965219 record still lists
NCT05965219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 4 interventions - of which Metformin is the first listed.
NCT05965219 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT05965219 about?
NCT05965219 is a clinical study titled "A Trial to Evaluate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of Emraclidine and of Emraclidine on the Pharmacokinetics of Metformin in Healthy Adult Participants". The primary purpose of the study is to evaluate the effect of itraconazole, a strong cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of emraclidine and metabolite CV-0000364 in Part A, the effect of carbamazepine, a strong CYP3A4 inducer, on the PK of emraclidine and metabolite CV-...
What is the current status of trial NCT05965219?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-08-15. Estimated completion is 2023-11-10.
What conditions does trial NCT05965219 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05965219?
The interventions under investigation include: Metformin (DRUG), Emraclidine (DRUG), Itraconazole (DRUG), Carbamazepine (DRUG).
Who is sponsoring clinical trial NCT05965219?
This trial is sponsored by Cerevel Therapeutics, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05965219 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05965219's enrollment target sits among peer trials
60 109th of 283 higher than 163 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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