NCT04690751

Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is an open-label, randomized, single-dose, single-center, three-period, six-sequence, balanced crossover study in healthy male and female subjects to assess the relative bioavailability of 200 mg of cenobamate given as an oral tablet or oral suspension and to evaluate the effect of food on the bioavailability of a 200 mg dose of cenobamate given as an oral suspension in fasting and fed conditions. The study consists of a 28-day screening period, followed by single dose administration of cenobamate (tablet or suspension) on Day 1, Day 22, and Day 43, an assessment period of 62 days and a follow-up visit on Day 69. All subjects will be confined to the clinical site from Day -1 (the day before period 1 dosing) until the morning of Day 4, Day 20 (the day of the last PK sampling for period 1) until the morning of Day 25, and Day 41 (the day of the last PK sampling for period 2) until the morning of Day 46. Outpatient visits will be performed regularly until the 456-hour PK sampling for each period. The follow-up visit will occur on Day 69 (±1 day).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cenobamate 200Mg Tab Fasted	Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients.
DRUG	Cenobamate Oral Suspension Fed	Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients.
DRUG	Cenobomate Oral Suspension Fasted	Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients.

Timeline

• Start date: 2020-12-21
• Primary completion: 2021-05-17
• Completion: 2021-05-17
• First posted: 2020-12-31
• Last updated: 2024-08-12
• Results posted: 2024-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study