NCT04791553

Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment

A Phase 1, Open-Label, Pharmacokinetic, Safety and Tolerability Study of a Single Oral Dose of Cenobamate (YKP3089) in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is designed investigate the effect of severe hepatic impairment on the pharmacokinetics (PK) of cenobamate.

Detailed description

This is a Phase 1, multi-center, open-label, non-randomized, parallel group PK and safety study of a single oral dose of cenobamate in male and female subjects with normal hepatic function (Group 1, n = 8) and those with severe hepatic impairment (Group 2, n = 8). The study consists of a 28-day screening period, followed by single dose administration of cenobamate (200mg) on Day 1, an assessment period of 35 days and follow-up visit. All subjects will be confined to the clinical site from Day -1 (the day before dosing) until Day 5. Outpatient visits will be performed regularly until Day 35. The follow-up visit will occur on Day 40 (±1 day).

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Cenobamate	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: 2021-06-17
• Primary completion: 2022-11-15
• Completion: 2023-08-11
• First posted: 2021-03-10
• Last updated: 2024-03-28

Locations

2 sites across 2 countries: Poland, Slovakia

Regulatory

• FDA-regulated drug study