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NCT03234699 · ClinicalTrials.gov registry record · Phase 1
Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions
A Phase 1 study, sponsored by SK Life Science.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03234699 is a Phase 1 study that has completed, run by SK Life Science. The registered enrollment target is 24 participants.
The verdict
NCT03234699, a Phase 1 study, has completed, sponsored by SK Life Science.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study is aimed to investigate the influence of cenobamate on the activity of CYP3A4/5, CYP2B6, CYP2C19, and CYP2C9 by using drugs recommended by both the FDA and EMA as in vivo probes. In order to avoid a potential pharmacokinetic interaction between the probes, midazolam (CYP3A), warfarin (CYP2C9), and omeprazole (CYP2C19) will be administered together as a validated cocktail and separately from bupropion (CYP2B6) using an adequate washout time period between the 2 assessments. The starting daily dose of cenobamate will be 12.5 mg, which will be administered for 2 weeks. Then, daily cenobamate doses will be increased every 2 weeks to 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. The CYP probes will be tested before cenobamate administration, at steady state at 100mg/day of cenobamate for midazolam only and finally at steady state at 200mg/day of cenobamate for all CYP probes. The results of this DDI study will provide a basis to make appropriate dose recommendation for a safe use of concomitant drugs with cenobamate using these isoenzymes in their metabolic pathway.
Interventions
- DRUG midazolam
- DRUG Cenobamate
- DRUG Warfarin Pill
- DRUG Omeprazole Pill
- DRUG Bupropion Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-02-22 |
| Est. Completion | 2017-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03234699
The ClinicalTrials.gov registry entry for NCT03234699 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SK Life Science, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which midazolam is the first listed.
NCT03234699 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03234699 about?
NCT03234699 is a clinical study titled "Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions". This study is aimed to investigate the influence of cenobamate on the activity of CYP3A4/5, CYP2B6, CYP2C19, and CYP2C9 by using drugs recommended by both the FDA and EMA as in vivo probes. In order to avoid a potential pharmacokinetic interaction between the probes, midazolam (CYP3A), warfarin (CYP...
What is the current status of trial NCT03234699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-02-22. Estimated completion is 2017-07-31.
What interventions are being tested in trial NCT03234699?
The interventions under investigation include: midazolam (DRUG), Cenobamate (DRUG), Warfarin Pill (DRUG), Omeprazole Pill (DRUG), Bupropion Pill (DRUG).
Who is sponsoring clinical trial NCT03234699?
This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.
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