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
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.
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).
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.
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.
Exclusion Criteria:
Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions
Drug: Cenobamate 200Mg Tab Fasted
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: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions
Drug: Cenobamate Oral Suspension Fed
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
Cmax
Maximum observed plasma concentration of cenobamate
Time frame: 120, 192, 264, 360, 456, hours post-dose
Tmax
Time to reach Maximum observed plasma concentration of cenobamate
Time frame: 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
Time frame: 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
Time frame: 120, 192, 264, 360, 456 hour post-dose
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
| Milestone | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 |
|---|---|---|---|---|---|---|
| Started | 4 | 5 | 5 | 4 | 6 | 4 |
| Completed | 4 | 4 | 4 | 3 | 3 | 4 |
| Not completed | 0 | 1 | 1 | 1 | 3 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 | 1 | 2 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Positive urine drug screen test | 0 | 0 | 0 | 0 | 1 | 0 |
Maximum observed plasma concentration of cenobamate
| (μg/mL) | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Cmax | 4.880 (3.77 to 6.66) | 4.680 (3.81 to 6.56) | 3.860 (3.25 to 4.75) |
Time to reach Maximum observed plasma concentration of cenobamate
| (h) | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Tmax | 3.000 (0.50 to 5.00) | 0.750 (0.50 to 3.50) | 5.000 (3.00 to 10.00) |
AUC from the time of dosing to the time of the last measurable concentration of cenobamate
| (μg•h/mL) | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Area Under the Concentration Curve to Last Measurable Concentration | 304.0 (178 to 516) | 302.5 (165 to 493) | 277.0 (17 to 494) |
Area Under the Concentration Curve (AUC) from time 0 extrapolated to infinity
| (μg•h/mL) | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Area Under the Concentration Curve From 0 to Infinity | 308.0 (183 to 526) | 309.5 (178 to 500) | 296.0 (178 to 500) |
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.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | 8 | 8 | 7 |
Collected over 69 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment A | 0/25 (0%) | 0/25 (0%) | 8/25 (32%) |
| Treatment B | 0/24 (0%) | 0/24 (0%) | 8/24 (33.3%) |
| Treatment C | 0/25 (0%) | 0/25 (0%) | 7/25 (28%) |
| Event | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| DizzinessNervous system disorders | 3/25 | 2/24 | 0/25 |
| HeadacheNervous system disorders | 1/25 | 1/24 | 1/25 |
| PresyncopeNervous system disorders | 0/25 | 1/24 | 0/25 |
| SomnolenceNervous system disorders | 0/25 | 1/24 | 0/25 |
| Euphoric MoodPsychiatric disorders | 0/25 | 1/24 | 0/25 |
| Oropharyngeal PainRespiratory, thoracic and mediastinal disorders | 0/25 | 1/24 | 1/25 |
| EcchymosisSkin and subcutaneous tissue disorders | 0/25 | 1/24 | 0/25 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 0/25 | 1/24 | 0/25 |
| PseudofolliculitisSkin and subcutaneous tissue disorders | 0/25 | 1/24 | 0/25 |
| Paraesthesia OralGastrointestinal disorders | 1/25 | 0/24 | 0/25 |
| Age, Continuous(years) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 28.0 ± 4.32 | 35.6 ± 11.67 | 30.6 ± 12.92 | 29.5 ± 8.74 | 28.5 ± 8.17 | 31.0 ± 5.48 | 30.6 ± 8.83 |
| Sex: Female, Male(Participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| Female | 1 | 1 | 1 | 0 | 1 | 1 | 5 |
| Male | 3 | 4 | 4 | 4 | 5 | 3 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 0 | 1 | 1 | 2 | 7 |
| Not Hispanic or Latino | 3 | 3 | 5 | 3 | 5 | 2 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 0 | 0 | 1 | 2 |
| Asian | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 | 0 | 0 | 2 |
| White | 4 | 2 | 5 | 3 | 6 | 3 | 23 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| United States | 4 | 5 | 5 | 4 | 6 | 4 | 28 |
| Weight(kg) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 74.45 ± 6.982 | 73.30 ± 10.458 | 77.52 ± 9.785 | 83.38 ± 10.779 | 72.93 ± 13.896 | 77.93 ± 13.178 | 76.24 ± 10.795 |
| Height(cm) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 174.93 ± 9.016 | 173.36 ± 8.993 | 180.72 ± 5.404 | 182.00 ± 0.469 | 172.13 ± 11.965 | 174.60 ± 13.879 | 176.05 ± 9.371 |
| Body Mass Index (BMI)(kg/m2) | Sequence 1 | Sequence 2 | Sequence 3 | Sequence 4 | Sequence 5 | Sequence 6 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 24.30 ± 1.128 | 24.38 ± 3.047 | 23.76 ± 2.919 | 25.15 ± 3.360 | 24.47 ± 3.133 | 25.58 ± 3.336 | 24.56 ± 2.726 |
Documents are hosted by the registry — open the source record to download them.
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.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cenobamate