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

Sponsor
SK Life Science, Inc.
Study ID
NCT04791553
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jun 17, 2021
Status verified
Mar 2024
Primary completion
Nov 15, 2022
Completion
Aug 11, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Normal Hepatic Function
    Group 1 single oral dose of 200 mg (2 x 100 mg tablet) cenobamate given to Matching healthy subjects with normal hepatic function
  • Experimental: Hepatic Impairment
    Group 2 single oral dose of 200 mg (2 x 100 mg tablet) cenobamate given to subjects with severe hepatic impairment

Primary Outcome Measure

Cmax [ Time Frame: 40 days ]

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