NCT05572255

A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally

A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally As a Crushed Tablet or a Crushed Tablet Via a Naso-gastric Tube Compared with an Intact 200 Mg Cenobamate Tablet

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3-period, 3-treatment crossover study in healthy adult male and female subjects to assess: the relative bioavailability of a crushed 200 mg, intact (whole) 200 mg and crushed 200 mg tablet via NG tube of cenobamate. All treatments will be administered under fasting conditions.

Detailed description

This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3- period, 3-treatment crossover study in healthy adult male and female subjects to assess: the relative bioavailability of a crushed 200 mg cenobamate table in suspension administrated orally (Treatment B, Test 1) compared to an intact (whole) 200 mg cenobamate tablet administered orally (Treatment A, Reference), and the relative bioavailability of a crushed 200 mg cenobamate tablet in suspension administered via an NG tube (Treatment C, Test 2) versus an intact (whole) 200 mg cenobamate tablet (Treatment A, Reference). All treatments will be administered under fasting conditions.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Cenobamate	200 mg Cenobamate Tablet

Timeline

• Start date: 2022-09-27
• Primary completion: 2023-01-28
• Completion: 2023-01-28
• First posted: 2022-10-07
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study