CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Cenobamate 200Mg Tab Fasted +2 moredrug
Likely dose
Cenobamate 200Mg Tab Fastedfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04690751
NCT04690751Phase 1Completed
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Relative Bioavailability of a Single 200 MG Dose Of Cenobamate (YKP3089) Given As An Oral Tablet Or As An Oral Suspension And The Effect Of Food On A Single 200 MG Dose Of Cenobamate Given As An Oral Suspension

SK Life Science, Inc.·interventional·Posted Dec 31, 2020·Updated Aug 12, 2024

In Brief

A Phase 1 clinical trial evaluating Cenobamate 200Mg Tab Fasted, Cenobamate Oral Suspension Fed, and 1 other intervention for Healthy. Completed, enrolled 28 participants across 1 site.

Detailed Summary

This study is designed to evaluate the relative bioavailability, or the degree and rate at which the drug is absorbed by the body of two cenobamate formulations (200 mg Oral Suspension and a 200 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the 200 mg Oral Suspension. This study will also look at the safety and tolerability of the oral suspension and the oral tablet under both fasted and fed conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedDec 31, 2020
Enrollment StartDec 21, 2020
Primary CompletionMay 17, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.5 years ago

Interventions

Cenobamate 200Mg Tab Fasteddrug

Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients.

Cenobamate Oral Suspension Feddrug

Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients.

Cenobomate Oral Suspension Fasteddrug

Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients.