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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: Completed Phase 1 study, sponsored by SK Life Science.
NCT03234699 is a Phase 1 study that has completed, run by SK Life Science. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be determined for S- and R-bupropion, total bupropion, midazolam, S-warfarin and R-warfarin, and omeprazole when administered with and without cenobamate at steady state
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 |
What the finished NCT03234699 record still lists
NCT03234699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which midazolam is the first listed.
NCT03234699 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03234699's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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