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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05965219
The ClinicalTrials.gov registry entry for NCT05965219 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The listed sponsor is Cerevel Therapeutics, which has 21 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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