Healthy VolunteersPhase 1NCT05572255
A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally
A Phase 1 study testing Cenobamate in people with Healthy Volunteers, run by SK Life Science, Inc. at 1 site in United States.
Trial summary
This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3-period, 3-treatment crossover study in healthy adult male and female subjects to assess: the relative bioavailability of a crushed 200 mg, intact (whole) 200 mg and crushed 200 mg tablet via NG tube of cenobamate. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cenobamate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2022to 28 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Body mass index (BMI) between 18.5 and 30.0 kg/m2 (inclusive) at screening
- 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 who have undergone a surgical 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.
- History of nasal obstructions or nasal allergies
- Smokers, including vaping (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 prescribed or over-the-counter medication prior to start of study drug intake (whichever is longer). Occasional use of acetaminophen is allowed up until 24 hours before dosing
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- 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), cotinine, 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)
- History of Familial Short QT syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally As a Crushed Tablet or a Crushed Tablet Via a Naso-gastric Tube Compared with an Intact 200 Mg Cenobamate Tablet
This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3-period, 3-treatment crossover study in healthy adult male and female subjects to assess: the relative bioavailability of a crushed 200 mg, intact (whole) 200 mg and crushed 200 mg tablet via NG tube of cenobamate. All treatments will be administered under fasting conditions.
Read the detailed description
This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3- period, 3-treatment crossover study in healthy adult male and female subjects to assess: the relative bioavailability of a crushed 200 mg cenobamate table in suspension administrated orally (Treatment B, Test 1) compared to an intact (whole) 200 mg cenobamate tablet administered orally (Treatment A, Reference), and the relative bioavailability of a crushed 200 mg cenobamate tablet in suspension administered via an NG tube (Treatment C, Test 2) versus an intact (whole) 200 mg cenobamate tablet (Treatment A, Reference). All treatments will be administered under fasting conditions.
- Conditions
- Healthy Volunteers
- Being tested
- Cenobamate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenobamateDrug
Also called YKP3089C045
200 mg Cenobamate Tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (Reference) | Experimental | An intact 200 mg cenobamate tablet administered orally. Receives: Drug: Cenobamate |
| Treatment B (Test 1) | Experimental | A crushed 200 mg cenobamate tablet in suspension administrated orally. Receives: Drug: Cenobamate |
| Treatment C (Test 2) | Experimental | A crushed 200 mg cenobamate tablet in suspension administered via an NG tube Receives: Drug: Cenobamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration
Measured: up to 38 days
AUClast
AUC from the time 0 to the time of last measurable concentration
Measured: up to 38 days
AUCinf (AUC0-inf)
AUC from time 0 extrapolated to infinity
Measured: up to 38 days
Secondary outcomes (6)
Safety and Tolerability - Adverse Events
Number of participants with adverse events (AEs)
Measured: up to 45 days
Safety and Tolerability - Clinical Laboratory Tests
Number of participants with clinical laboratory tests including clinical chemistry, hematology, coagulation, and urinalysis.
Measured: up to 45 days
Safety and Tolerability - Vitals Signs
Number of participants with vitals signs including systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature
Measured: up to 45 days
Safety and Tolerability - Physical Examination
Number of participants with physical examination
Measured: up to 45 days
Safety and Tolerability - ECG
Number of participants with ECG QT and RR Intervals
Measured: up to 45 days
Safety and Tolerability - Columbia Suicide Severity Rating Scale
Number of participants with Columbia Suicide Severity Rating Scale
Measured: up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start27 Sep 2022
- Primary completion28 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Crossover
- Model description
- Single-dose, 6-sequence, 3-period, 3-treatment crossover study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vijaykumar Vashi, Study director, SKLSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572255
- Sponsor's protocol ID
- YKP3089C045
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally As a Crushed Tablet or a Crushed Tablet Via a Naso-gastric Tube Compared with an Intact 200 Mg Cenobamate Tablet
- ClinicalTrials.gov ID
- NCT05572255
- Acronym / sponsor ID
- YKP3089C045
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
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 a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3-period, 3-treatment crossover study in healthy adult male and female subjects to assess: the relative bioavailability of a crushed 200 mg, intact (whole) 200 mg and crushed 200 mg tablet via NG tube of cenobamate. All treatments will be administered under fasting conditions.
Detailed description
This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3- period, 3-treatment crossover study in healthy adult male and female subjects to assess: the relative bioavailability of a crushed 200 mg cenobamate table in suspension administrated orally (Treatment B, Test 1) compared to an intact (whole) 200 mg cenobamate tablet administered orally (Treatment A, Reference), and the relative bioavailability of a crushed 200 mg cenobamate tablet in suspension administered via an NG tube (Treatment C, Test 2) versus an intact (whole) 200 mg cenobamate tablet (Treatment A, Reference). All treatments will be administered under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single-dose, 6-sequence, 3-period, 3-treatment crossover study
| Arm | Type | Receives |
|---|---|---|
| Treatment A (Reference) | Experimental | Drug: CenobamateAn intact 200 mg cenobamate tablet administered orally. |
| Treatment B (Test 1) | Experimental | Drug: CenobamateA crushed 200 mg cenobamate tablet in suspension administrated orally. |
| Treatment C (Test 2) | Experimental | Drug: CenobamateA crushed 200 mg cenobamate tablet in suspension administered via an NG tube |
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
- Body mass index (BMI) between 18.5 and 30.0 kg/m2 (inclusive) at screening
- 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.
- History of nasal obstructions or nasal allergies
- Smokers, including vaping (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)
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 |
|---|---|---|
| CenobamateAlso: YKP3089C045200 mg Cenobamate Tablet | Drug | Treatment A (Reference), Treatment B (Test 1), Treatment C (Test 2) |
Primary outcome
Cmax
Time frame: up to 38 days
Maximum observed plasma concentration
AUClast
Time frame: up to 38 days
AUC from the time 0 to the time of last measurable concentration
AUCinf (AUC0-inf)
Time frame: up to 38 days
AUC from time 0 extrapolated to infinity
6 secondary outcomes
Safety and Tolerability - Adverse Events
Time frame: up to 45 days
Safety and Tolerability - Clinical Laboratory Tests
Time frame: up to 45 days
Safety and Tolerability - Vitals Signs
Time frame: up to 45 days
Safety and Tolerability - Physical Examination
Time frame: up to 45 days
Safety and Tolerability - ECG
Time frame: up to 45 days
Safety and Tolerability - Columbia Suicide Severity Rating Scale
Time frame: up to 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Vijaykumar Vashi study director
SKLSI
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 in people with Healthy Volunteers, 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 19 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: up to 38 days). The study lists 3 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 19 Sep 2024.