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

NCT04690751 | Completed Phase 1 Results FDA Drug

• 1 other identifier: YKP3089C037
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Cmax

  Maximum observed plasma concentration of cenobamate

  120, 192, 264, 360, 456, hours post-dose

• Tmax

  Time to reach Maximum observed plasma concentration of cenobamate

  120, 192, 264, 360, 456 hour post-dose

• Area Under the Concentration Curve to Last Measurable Concentration

  AUC from the time of dosing to the time of the last measurable concentration of cenobamate

  120, 192, 264, 360, 456 hour post-dose

• Area Under the Concentration Curve From 0 to Infinity

  Area Under the Concentration Curve (AUC) from time 0 extrapolated to infinity

  120, 192, 264, 360, 456 hour post-dose

Secondary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events

  Day 1 to Day 69

Study Arms (3)

Treatment A

EXPERIMENTAL

Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions

Drug: Cenobamate 200Mg Tab Fasted

Treatment B

EXPERIMENTAL

Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions

Drug: Cenobomate Oral Suspension Fasted

Treatment C

EXPERIMENTAL

Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions

Drug: Cenobamate Oral Suspension Fed

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.

Also known as: YKP3089

Treatment A

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.

Also known as: YKP3089

Treatment C

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.

Also known as: YKP3089

Treatment B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects of 18 to 50 years of age (inclusive), at the time of screening
• Able to read, understand, sign, and date a written informed consent form (ICF) before study participation at screening
• Agree to use effective methods of contraception as described in Section 12.1.7.8 and Section 12.1.7.9.
• Body mass index (BMI) between 18.5 and 30.0 kg/m2 (inclusive) at screening
• Judged to be in good health on the basis of medical history, physical examination, and routine laboratory measurements (i.e., without clinically relevant pathology)
• Electrocardiogram (ECG) (12-lead), arterial blood pressure, and heart rate within the normal range of the study center or considered not clinically significant by the Investigator.
• Able to understand and comply with protocol requirements and instructions and likely to complete the study as planned
• Females of non-childbearing potential (18 to 50 years of age (inclusive)), who have undergone a sterilization procedure at least 6 months prior to dosing with official documentation (e.g., bilateral tubal ligation or bilateral salpingectomy or hysterectomy), or be postmenopausal with amenorrhea for at least 1 year prior to dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status as per Principal Investigator's judgment

You may not qualify if:

• Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at Screening that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer
• Smokers (subjects who have smoked within 6 months at screening)
• History of any drug related hypersensitivity reactions as well as severe hypersensitivity reactions (like angioedema) or DRESS as evaluated by the Investigator
• Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the study drug (except appendectomy and simple hernia repair)
• Any prescribed or over-the-counter medication taken within 2 weeks prior to start of administration of study drug (Day 1) or within 6 times the elimination half-life of the medication prior to start of study drug intake (whichever is longer). Occasional use of acetaminophen is allowed up until 24 hours before dosing
• Consumption of herbal medications, dietary supplements and specific fruit products. Subjects should have stopped consumption of herbal medications or dietary supplements (e.g., St. John's Wort, ginkgo biloba, and garlic supplements), and grapefruit or grapefruit juice, or Seville oranges at least 2 weeks before the first dosing day of study drug. Vitamins/mineral supplements are allowed up until 24 hours before dosing
• History of drug or alcohol abuse or addiction within 2 years before the start of study drug dosing, or a positive test results for alcohol or drugs of abuse, such as amphetamine, barbiturate, benzodiazepine, cocaine, methadone, opiates, oxycodone, phencyclidine, propoxyphene, cannabinoid (THC), MDMA (Ecstasy), methaqualone, and tricyclic antidepressant (TCA)
• Regular consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week (1 unit of alcohol equals 1 pint \[473 mL\] of beer or lager, 1 glass \[125 mL\] of wine, 25 mL shot of 40% spirit) before screening
• Consumption of an average of more than 5 servings (8 ounces per serving) per day of coffee, cola, or other caffeinated or methyl xanthine beverages before screening
• Consumption of any caffeine- or methyl xanthine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours prior to Day 1 of each period and until the end of each PK sampling period
• Participation in a clinical study involving administration of either an investigational or a marketed drug within 2 months or 7 half-lives (whichever is longer) before screening
• Blood donation or a significant loss of blood within 60 days of the start of study drug dosing or donation of more than 1 unit of plasma within 7 days before screening
• Positive result at screening for any of the following infectious disease tests: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antigen and antibody (HIV Ag, HIV Ab)
• Illness within 5 days before the start of study drug dosing ("illness" is defined as an acute \[serious or non-serious\] condition \[e.g., the flu or the common cold\])
• History of any known relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)

Sponsors & Collaborators

• SK Life Science, Inc.: lead

Study Sites (1)

PRA Health Sciences Salt Lake City

Millcreek, Utah, 84124, United States

Location

MeSH Terms

Interventions

Cenobamate

Results Point of Contact

• Title: Executive Director and Head, Clinical Pharmacology
• Organization: SK Life Science, Inc.

vvashi@sklsi.com

862-271-2645

Study Officials

• Stephen Greene, PharmD

  SK Life Science, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: • 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

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 31, 2020
• Study Start: December 21, 2020
• Primary Completion: May 17, 2021
• Study Completion: May 17, 2021
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-03

Locations

US (1)