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

Part of paid clinical trials in Millcreek, Utah.

Sponsor
SK Life Science, Inc.
Study ID
NCT04690751
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Cenobamate 200Mg Tab Fasted — DRUG
    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 Fed — DRUG
    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 Fasted — 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 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.

Key Dates

Start date
Dec 21, 2020
Status verified
Mar 2024
Primary completion
May 17, 2021
Completion
May 17, 2021

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment A
    Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions
  • Experimental: Treatment B
    Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions
  • Experimental: Treatment C
    Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions

Primary Outcome Measure

Cmax [ Time Frame: 120, 192, 264, 360, 456, hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
PRA Health Sciences Salt Lake CityMillcreekUtah84124-

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PRA Health Sciences Salt Lake City· Millcreek, UT

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