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CompletedNCT04690751Updated Aug 12, 2024Results posted

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

A Phase 1 interventional study of Cenobamate 200Mg Tab Fasted and Cenobamate Oral Suspension Fed in Healthy, sponsored by SK Life Science, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by SK Life Science, Inc. (part of SK Biopharmaceuticals) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the detailed description

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.

The study consists of a 28-day screening period, followed by single dose administration of cenobamate (tablet or suspension) on Day 1, Day 22, and Day 43, an assessment period of 62 days and a follow-up visit on Day 69. All subjects will be confined to the clinical site from Day -1 (the day before period 1 dosing) until the morning of Day 4, Day 20 (the day of the last PK sampling for period 1) until the morning of Day 25, and Day 41 (the day of the last PK sampling for period 2) until the morning of Day 46. Outpatient visits will be performed regularly until the 456-hour PK sampling for each period. The follow-up visit will occur on Day 69 (±1 day).

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

SK Life Science, Inc. is the lead sponsor of 43 studies on the registry; 2 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 2 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female subjects of 18 to 50 years of age (inclusive), at the time of screening
  2. Able to read, understand, sign, and date a written informed consent form (ICF) before study participation at screening
  3. Agree to use effective methods of contraception as described in Section 12.1.7.8 and Section 12.1.7.9.
  4. Body mass index (BMI) between 18.5 and 30.0 kg/m2 (inclusive) at screening
  5. Judged to be in good health on the basis of medical history, physical examination, and routine laboratory measurements (i.e., without clinically relevant pathology)
  6. 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.
  7. Able to understand and comply with protocol requirements and instructions and likely to complete the study as planned
  8. 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

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Smokers (subjects who have smoked within 6 months at screening)
  3. History of any drug related hypersensitivity reactions as well as severe hypersensitivity reactions (like angioedema) or DRESS as evaluated by the Investigator
  4. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the study drug (except appendectomy and simple hernia repair)
  5. 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
  6. 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
  7. 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)
  8. 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
  9. 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
  10. 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
  11. 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
  12. 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
  13. 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)
  14. 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])
  15. History of any known relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
  16. Subject who is judged not eligible for study participation by Investigator
  17. History of Familial Short QT syndrome.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Treatment A

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

    Drug: Cenobamate 200Mg Tab Fasted

  • Experimental
    Treatment B

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

    Drug: Cenobomate Oral Suspension Fasted

  • Experimental
    Treatment C

    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 (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

  • 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

  • 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

06

What researchers measure

Primary outcomes

  1. Cmax

    Maximum observed plasma concentration of cenobamate

    Time frame: 120, 192, 264, 360, 456, hours post-dose

  2. Tmax

    Time to reach Maximum observed plasma concentration of cenobamate

    Time frame: 120, 192, 264, 360, 456 hour post-dose

  3. 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

    Time frame: 120, 192, 264, 360, 456 hour post-dose

  4. Area Under the Concentration Curve From 0 to Infinity

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

    Time frame: 120, 192, 264, 360, 456 hour post-dose

Secondary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events

    To evaluate the safety and tolerability of each cenobamate formulation administered under either fed (Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension ) or fasted (Both tablet and oral suspension formulations) incidence of treatment-emergent adverse events will be monitored.

    Time frame: Day 1 to Day 69

07

Results

Posted Aug 12, 2024

Participant flow

Participant flow — Overall Study
MilestoneSequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
Started455464
Completed444334
Not completed011130
Withdrew: Protocol violation010120
Withdrew: Adverse event001000
Withdrew: Positive urine drug screen test000010

Outcome measures

PrimaryCmax

Maximum observed plasma concentration of cenobamate

Time frame:
120, 192, 264, 360, 456, hours post-dose
Reported as:
Median · (μg/mL)
Cmax
(μg/mL)Treatment ATreatment BTreatment C
Cmax4.880 (3.77 to 6.66)4.680 (3.81 to 6.56)3.860 (3.25 to 4.75)
PrimaryTmax

Time to reach Maximum observed plasma concentration of cenobamate

Time frame:
120, 192, 264, 360, 456 hour post-dose
Reported as:
Median · (h)
Tmax
(h)Treatment ATreatment BTreatment C
Tmax3.000 (0.50 to 5.00)0.750 (0.50 to 3.50)5.000 (3.00 to 10.00)
PrimaryArea Under the Concentration Curve to Last Measurable Concentration

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

Time frame:
120, 192, 264, 360, 456 hour post-dose
Reported as:
Median · (μg•h/mL)
Area Under the Concentration Curve to Last Measurable Concentration
(μg•h/mL)Treatment ATreatment BTreatment C
Area Under the Concentration Curve to Last Measurable Concentration304.0 (178 to 516)302.5 (165 to 493)277.0 (17 to 494)
PrimaryArea Under the Concentration Curve From 0 to Infinity

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

Time frame:
120, 192, 264, 360, 456 hour post-dose
Reported as:
Median · (μg•h/mL)
Area Under the Concentration Curve From 0 to Infinity
(μg•h/mL)Treatment ATreatment BTreatment C
Area Under the Concentration Curve From 0 to Infinity308.0 (183 to 526)309.5 (178 to 500)296.0 (178 to 500)
SecondaryNumber of Participants With Treatment-Emergent Adverse Events

To evaluate the safety and tolerability of each cenobamate formulation administered under either fed (Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension ) or fasted (Both tablet and oral suspension formulations) incidence of treatment-emergent adverse events will be monitored.

Time frame:
Day 1 to Day 69
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events
ParticipantsTreatment ATreatment BTreatment C
Number of Participants With Treatment-Emergent Adverse Events887

Adverse events

Collected over 69 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment A0/25 (0%)0/25 (0%)8/25 (32%)
Treatment B0/24 (0%)0/24 (0%)8/24 (33.3%)
Treatment C0/25 (0%)0/25 (0%)7/25 (28%)
Most frequent other events
Showing 10 of 22
Most frequent other events
EventTreatment ATreatment BTreatment C
DizzinessNervous system disorders3/252/240/25
HeadacheNervous system disorders1/251/241/25
PresyncopeNervous system disorders0/251/240/25
SomnolenceNervous system disorders0/251/240/25
Euphoric MoodPsychiatric disorders0/251/240/25
Oropharyngeal PainRespiratory, thoracic and mediastinal disorders0/251/241/25
EcchymosisSkin and subcutaneous tissue disorders0/251/240/25
HyperhidrosisSkin and subcutaneous tissue disorders0/251/240/25
PseudofolliculitisSkin and subcutaneous tissue disorders0/251/240/25
Paraesthesia OralGastrointestinal disorders1/250/240/25

Baseline characteristics

Age, Continuous
Age, Continuous(years)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
Mean28.0 ± 4.3235.6 ± 11.6730.6 ± 12.9229.5 ± 8.7428.5 ± 8.1731.0 ± 5.4830.6 ± 8.83
Sex: Female, Male
Sex: Female, Male(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
Female1110115
Male34445323
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
Hispanic or Latino1201127
Not Hispanic or Latino33535221
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
American Indian or Alaska Native0100012
Asian0100001
Native Hawaiian or Other Pacific Islander0000000
Black or African American0101002
White42536323
More than one race0000000
Unknown or Not Reported0000000
Region of Enrollment
Region of Enrollment(participants)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
United States45546428
Weight
Weight(kg)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
Mean74.45 ± 6.98273.30 ± 10.45877.52 ± 9.78583.38 ± 10.77972.93 ± 13.89677.93 ± 13.17876.24 ± 10.795
Height
Height(cm)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
Mean174.93 ± 9.016173.36 ± 8.993180.72 ± 5.404182.00 ± 0.469172.13 ± 11.965174.60 ± 13.879176.05 ± 9.371
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m2)Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6Total
Mean24.30 ± 1.12824.38 ± 3.04723.76 ± 2.91925.15 ± 3.36024.47 ± 3.13325.58 ± 3.33624.56 ± 2.726
08

Study locations

1 site
  • PRA Health Sciences Salt Lake City
    Millcreek, Utah 84124, United States
09

References and documents

Study documents

  • Study protocol · Nov 30, 2020
  • Statistical analysis plan · Jul 26, 2021

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2020 to primary completion in May 2021, 4 months.

Results were first posted in Aug 2024, 3 years 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2020
First posted
Dec 31, 2020
StartActual
Dec 21, 2020
Primary completionActual
May 17, 2021
CompletionActual
May 17, 2021
Results first posted
Aug 12, 2024
Last update
Aug 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04690751
Responsible party
Sponsor
First posted
Dec 31, 2020
Start date
Dec 21, 2020
Primary completion
May 17, 2021
Completion
May 17, 2021
Results posted
Aug 12, 2024
Last update
Aug 12, 2024

Study contacts

Stephen Greene, PharmD
study chair · SK Life Science, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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