HealthyPhase 1NCT04690751
Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet
A Phase 1 study testing Cenobamate 200Mg Tab Fasted, Cenobamate Oral Suspension Fed and Cenobomate Oral Suspension Fasted in people with Healthy, run by SK Life Science, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cenobamate 200Mg Tab Fasted, Cenobamate Oral Suspension Fed and Cenobomate Oral Suspension Fasted
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2020to 17 May 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
- Subject who is judged not eligible for study participation by Investigator
- History of Familial Short QT syndrome.
Trial locations and contacts
1 site in 1 country.
United States1 site
PRA Health Sciences Salt Lake City
Millcreek, Utah, 84124
About this study
Official title: Relative Bioavailability of a Single 200 MG Dose Of Cenobamate (YKP3089) Given As An Oral Tablet Or As An Oral Suspension And The Effect Of Food On A Single 200 MG Dose Of Cenobamate Given As An Oral Suspension
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).
- Conditions
- Healthy
- Being tested
- Cenobamate 200Mg Tab Fasted, Cenobamate Oral Suspension Fed, Cenobomate Oral Suspension Fasted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cenobamate 200Mg Tab FastedDrug
Also called YKP3089
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 FedDrug
Also called YKP3089
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 FastedDrug
Also called YKP3089
Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions Receives: 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 Receives: 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 Receives: Drug: Cenobamate Oral Suspension Fed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration of cenobamate
Measured: 120, 192, 264, 360, 456, hours post-dose
Tmax
Time to reach Maximum observed plasma concentration of cenobamate
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 1 to Day 69
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start21 Dec 2020
- Primary completion17 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model 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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Greene, PharmD, Study chair, SK Life Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690751
- Sponsor's protocol ID
- YKP3089C037
- Status last verified
- Mar 2024
- First submitted
- 10 Dec 2020
- Last updated
- 12 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of a Single 200 MG Dose Of Cenobamate (YKP3089) Given As An Oral Tablet Or As An Oral Suspension And The Effect Of Food On A Single 200 MG Dose Of Cenobamate Given As An Oral Suspension
- ClinicalTrials.gov ID
- NCT04690751
- Acronym / sponsor ID
- YKP3089C037
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Posted 12 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model 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
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Cenobamate 200Mg Tab FastedTreatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions |
| Treatment B | Experimental | Drug: Cenobomate Oral Suspension FastedTreatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions |
| Treatment C | Experimental | Drug: Cenobamate Oral Suspension FedTreatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cenobamate 200Mg Tab FastedAlso: YKP3089Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients. | Drug | Treatment A |
| Cenobamate Oral Suspension FedAlso: YKP3089Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients. | Drug | Treatment C |
| Cenobomate Oral Suspension FastedAlso: YKP3089Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients. | Drug | Treatment B |
Primary outcome
Cmax
Time frame: 120, 192, 264, 360, 456, hours post-dose
Maximum observed plasma concentration of cenobamate
Tmax
Time frame: 120, 192, 264, 360, 456 hour post-dose
Time to reach Maximum observed plasma concentration of cenobamate
Area Under the Concentration Curve to Last Measurable Concentration
Time frame: 120, 192, 264, 360, 456 hour post-dose
AUC from the time of dosing to the time of the last measurable concentration of cenobamate
Area Under the Concentration Curve From 0 to Infinity
Time frame: 120, 192, 264, 360, 456 hour post-dose
Area Under the Concentration Curve (AUC) from time 0 extrapolated to infinity
1 secondary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Day 1 to Day 69
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Greene, PharmD study chair
SK Life Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cenobamate 200Mg Tab Fasted, Cenobamate Oral Suspension Fed and Cenobomate Oral Suspension Fasted in people with Healthy, run by SK Life Science, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 120, 192, 264, 360, 456, hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.