Healthy VolunteerPhase 1NCT03509285
A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users
A Phase 1 study testing Alprazolam and Cenobamate in people with Healthy Volunteer, run by SK Life Science, Inc. at 2 sites in 2 countries.
Trial summary
This randomized, single-dose, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of cenobamate in recreational drug users with sedative drug use experience. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Alprazolam and Cenobamate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Mar 2017to 15 Dec 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects 18 to 55 years of age, inclusive.
- Body mass index (BMI) within the range of 19.0 to 32.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
- Current recreational drug users who have used benzodiazepines for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least 5 times in the past year and used benzodiazepines at least once in the 12 weeks before Screening.
- Female subjects of childbearing potential with male sexual partners must be using and willing to continue using medically acceptable contraception (as specified in Section 4.5.2) for at least 1 month prior to Screening (at least 3 months for oral and transdermal contraceptives) and for at least 30 days after the last study drug administration.
- Female subjects of non-childbearing potential must meet the criteria specified in Section 4.5.2.
- Male subjects with female sexual partners of childbearing potential must be using and willing to continue using medically acceptable contraception (as specified in Section 4.5.2) from Screening and for at least 30 days after the last study drug administration.
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- Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
- Must understand and provide written informed consent, prior to the initiation of any protocol-specific procedures.
- Must be willing to comply with the requirements and restrictions of the study.
Who cannot join
- Substance or alcohol dependence within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition - Text Revision (DSM IV-TR), and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence (excluding nicotine and caffeine).
- Heavy smoker (>20 cigarettes per day) and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine-containing products for at least 10 hours during the in-clinic periods (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine-topical patches, nicotine gum, or nicotine lozenges).
- History or presence of clinically significant abnormality as assessed by physical examination, medical history (including cholecystectomy), ECGs, vital signs, or laboratory values, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results.
- History or presence of myasthenia gravis, severe hepatic insufficiency, severe respiratory insufficiency, sleep apnea syndrome, or acute narrow angle glaucoma.
- Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5× the upper limit of normal (ULN), or bilirubin >1× ULN. Repeat safety laboratory tests are allowed once for Screening, unless the principal investigator and sponsor agree to an additional repeat.
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- Donation or loss of more than 500 mL whole blood within 30 days preceding entry into the Treatment Phase.
- Difficulty with venous access or unsuitable or unwilling to undergo catheter insertion.
- Female subjects who are currently pregnant (have a positive pregnancy test) or lactating or who are planning to become pregnant within 30 days of last study drug administration.
- History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus.
- Subject history of allergy, hypersensitivity, or DRESS syndrome to any drug product including anti-convulsants (e.g., alprazolam, carbamazepine) or related drugs (e.g., other benzodiazepines) or known excipients of any of the drug products in this study. History of a first degree relative with a serious cutaneous drug-induced adverse reaction.
- Subjects with any history of suicidal ideation or suicidal behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C SSRS; baseline version).
- Use of a prohibited medication or investigational drug, including exposure to any drugs associated with DRESS syndrome (e.g., allopurinol, minocycline, abacavir, lamotrigine) in the 6 months prior to Screening.
- Use of a prohibited medication, as specified in Section 4.5.1.
- Treatment with an investigational drug within 5 times the elimination half-life, if known (e.g., a marketed product), or within 30 days (if the elimination half-life is unknown) prior to the first study drug administration or is concurrently enrolled in any research judged not be scientifically or medically compatible with this study.
- An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family member defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- A subject who has pending legal charges or is on probation.
- A subject who, in the opinion of the investigator or designee, is considered unsuitable or unlikely to comply with the study protocol for any reason.
- Anyone who has previously been exposed to cenobamate (prior to participation in this study).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Vince & Associates Clinical Research, Inc
Overland Park, Kansas, 66212
About this study
Official title: Randomized, Double-Blind, Double-Dummy, 5-Way Crossover Study to Evaluate the Abuse Potential of Cenobamate Relative to Alprazolam and Placebo When Administered Orally in Non-Dependent, Recreational Drug Users with Sedative Experience
This randomized, single-dose, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of cenobamate in recreational drug users with sedative drug use experience.
In the Qualification phase, subjects will receive a single dose of either alprazolam or placebo in a crossover design, with a wash-out period of at least 24 hours between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the Treatment phase and will be randomized to single oral doses of cenobamate (2 dose levels), alprazolam (2 dose levels), and placebo in a double-blind, double-dummy, 5-way crossover design. Washout-periods between the 5 treatment periods in the Treatment phase will be at least 16 days.
- Conditions
- Healthy Volunteer
- Being tested
- Alprazolam Placebo, Cenobamate placebo, Alprazolam, Cenobamate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprazolam PlaceboDrug
100 mg lactose tablets
Cenobamate placeboDrug
Sugar pill manufactured to mimic cenobamate 100 mg tablet
AlprazolamDrug
0.5 mg and 1.0 mg alprazolam tablets
CenobamateDrug
100 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Qualification Y | Placebo comparator | Placebo; administered orally as a single dose of 2 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo) Receives: Drug: Alprazolam Placebo |
| Qualification Z | Active comparator | Alprazolam 2.0 mg; administered orally as a single dose of 2 x 1.0 mg alprazolam tablets, over-encapsulated Receives: Drug: Alprazolam |
| Treatment A | Placebo comparator | Placebo; administered orally as a single dose of 4 x cenobamate-matched placebo tablets and 3 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo) Receives: Drug: Alprazolam Placebo; Drug: Cenobamate placebo |
| Treatment B | Active comparator | Alprazolam 1.5 mg; administered orally as a single dose of 3 x 0.5 mg alprazolam tablets, over-encapsulated and 4 x cenobamate-matched placebo tablets Receives: Drug: Cenobamate placebo; Drug: Alprazolam |
| Treatment C | Active comparator | Alprazolam 3.0 mg; administered orally as a single dose of 3 x 1.0 mg alprazolam tablets, over-encapsulated and 4 x cenobamate-matched placebo tablets Receives: Drug: Cenobamate placebo; Drug: Alprazolam |
| Treatment D | Experimental | Cenobamate, 200 mg; administered orally as a single dose of 2 x 100 mg cenobamate tablets, 2 x cenobamate-matched placebo tablets, and 3 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo) Receives: Drug: Alprazolam Placebo; Drug: Cenobamate placebo; Drug: Cenobamate |
| Treatment E | Experimental | Cenobamate, 400 mg; administered orally as a single dose of 4 x 100 mg cenobamate tablets and 3 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo) Receives: Drug: Alprazolam Placebo; Drug: Cenobamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics using Visual Analogue Scales (VAS)
Subjective Effect of Drug Liking "at this moment" [0-100 scale, 0=Strong Disliking, 50=Neither Like nor Dislike, 100=Strong Liking]
Measured: Measured for 24 hrs in each Treatment Period
Secondary outcomes (6)
Pharmacokinetics
Plasma concentrations of cenobamate and alprazolam
Measured: Measured for 24 hrs in each Treatment Period
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Incidence, frequency, and severity of AEs and AEs of Special Interest (which include AEs related to drug reaction with eosinophilia and systemic symptoms [DRESS] and abuse-related adverse events)
Measured: 21 weeks
Pharmacodynamics using Visual Analogue Scales (VAS)
Subjective Effect of Take Drug Again [0-100 scale, 0=Definitely Not, 50=Neutral, 100=Definitely So]
Measured: Measured at 12 hr and 24 hr timepoints in each Treatment Period
Pharmacodynamics using Visual Analogue Scales (VAS)
Subjective Effect of Overall Drug Liking [0-100 scale, 0=Strong Disliking, 50=Neither Like nor Dislike, 100=Strong Liking]
Measured: Measured at 12 hr and 24 hr timepoints in each Treatment Period
Pharmacodynamics using Visual Analogue Scales (VAS)
Subjective Effect of High [0-100 scale, 0=Not at All,100=Extremely]
Measured: Measured for 24 hrs in each Treatment Period
Pharmacodynamics using Visual Analogue Scales (VAS)
Subjective Good Drug Effects [0-100 scale, 0=Not at All,100=Extremely]
Measured: Measured for 24 hrs in each Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start8 Mar 2017
- Primary completion18 Nov 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509285
- Sponsor's protocol ID
- YKP3089C024
- Status last verified
- Nov 2024
- First submitted
- 17 Apr 2017
- Last updated
- 7 Nov 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Double-Dummy, 5-Way Crossover Study to Evaluate the Abuse Potential of Cenobamate Relative to Alprazolam and Placebo When Administered Orally in Non-Dependent, Recreational Drug Users with Sedative Experience
- ClinicalTrials.gov ID
- NCT03509285
- Acronym / sponsor ID
- YKP3089C024
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 18 Nov 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 26 Apr 2018 (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 randomized, single-dose, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of cenobamate in recreational drug users with sedative drug use experience.
In the Qualification phase, subjects will receive a single dose of either alprazolam or placebo in a crossover design, with a wash-out period of at least 24 hours between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the Treatment phase and will be randomized to single oral doses of cenobamate (2 dose levels), alprazolam (2 dose levels), and placebo in a double-blind, double-dummy, 5-way crossover design. Washout-periods between the 5 treatment periods in the Treatment phase will be at least 16 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Qualification Y | Placebo comparator | Drug: Alprazolam PlaceboPlacebo; administered orally as a single dose of 2 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo) |
| Qualification Z | Active comparator | Drug: AlprazolamAlprazolam 2.0 mg; administered orally as a single dose of 2 x 1.0 mg alprazolam tablets, over-encapsulated |
| Treatment A | Placebo comparator | Drug: Alprazolam Placebo, Drug: Cenobamate placeboPlacebo; administered orally as a single dose of 4 x cenobamate-matched placebo tablets and 3 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo) |
| Treatment B | Active comparator | Drug: Cenobamate placebo, Drug: AlprazolamAlprazolam 1.5 mg; administered orally as a single dose of 3 x 0.5 mg alprazolam tablets, over-encapsulated and 4 x cenobamate-matched placebo tablets |
| Treatment C | Active comparator | Drug: Cenobamate placebo, Drug: AlprazolamAlprazolam 3.0 mg; administered orally as a single dose of 3 x 1.0 mg alprazolam tablets, over-encapsulated and 4 x cenobamate-matched placebo tablets |
| Treatment D | Experimental | Drug: Alprazolam Placebo, Drug: Cenobamate placebo, Drug: CenobamateCenobamate, 200 mg; administered orally as a single dose of 2 x 100 mg cenobamate tablets, 2 x cenobamate-matched placebo tablets, and 3 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo) |
| Treatment E | Experimental | Drug: Alprazolam Placebo, Drug: CenobamateCenobamate, 400 mg; administered orally as a single dose of 4 x 100 mg cenobamate tablets and 3 x 100 mg lactose tablets, over-encapsulated (alprazolam placebo) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female subjects 18 to 55 years of age, inclusive.
- Body mass index (BMI) within the range of 19.0 to 32.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
- Current recreational drug users who have used benzodiazepines for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least 5 times in the past year and used benzodiazepines at least once in the 12 weeks before Screening.
- Female subjects of childbearing potential with male sexual partners must be using and willing to continue using medically acceptable contraception (as specified in Section 4.5.2) for at least 1 month prior to Screening (at least 3 months for oral and transdermal contraceptives) and for at least 30 days after the last study drug administration.
- Female subjects of non-childbearing potential must meet the criteria specified in Section 4.5.2.
Key exclusion criteria (19 listed)
- Substance or alcohol dependence within the past 2 years, as defined by the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition - Text Revision (DSM IV-TR), and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence (excluding nicotine and caffeine).
- Heavy smoker (>20 cigarettes per day) and/or is unable to abstain from smoking or unable to abstain from the use of prohibited nicotine-containing products for at least 10 hours during the in-clinic periods (including e-cigarettes, pipes, cigars, chewing tobacco, nicotine-topical patches, nicotine gum, or nicotine lozenges).
- History or presence of clinically significant abnormality as assessed by physical examination, medical history (including cholecystectomy), ECGs, vital signs, or laboratory values, which in the opinion of the investigator would jeopardize the safety of the subject or the validity of the study results.
- History or presence of myasthenia gravis, severe hepatic insufficiency, severe respiratory insufficiency, sleep apnea syndrome, or acute narrow angle glaucoma.
- Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
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 |
|---|---|---|
| Alprazolam Placebo100 mg lactose tablets | Drug | Qualification Y, Treatment A, Treatment D, Treatment E |
| Cenobamate placeboSugar pill manufactured to mimic cenobamate 100 mg tablet | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
| Alprazolam0.5 mg and 1.0 mg alprazolam tablets | Drug | Qualification Z, Treatment B, Treatment C |
| Cenobamate100 mg tablet | Drug | Treatment D, Treatment E |
Primary outcome
Pharmacodynamics using Visual Analogue Scales (VAS)
Time frame: Measured for 24 hrs in each Treatment Period
Subjective Effect of Drug Liking "at this moment" [0-100 scale, 0=Strong Disliking, 50=Neither Like nor Dislike, 100=Strong Liking]
6 secondary outcomes
Pharmacokinetics
Time frame: Measured for 24 hrs in each Treatment Period
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: 21 weeks
Pharmacodynamics using Visual Analogue Scales (VAS)
Time frame: Measured at 12 hr and 24 hr timepoints in each Treatment Period
Pharmacodynamics using Visual Analogue Scales (VAS)
Time frame: Measured at 12 hr and 24 hr timepoints in each Treatment Period
Pharmacodynamics using Visual Analogue Scales (VAS)
Time frame: Measured for 24 hrs in each Treatment Period
Pharmacodynamics using Visual Analogue Scales (VAS)
Time frame: Measured for 24 hrs in each Treatment Period
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 7 Nov 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alprazolam and Cenobamate in people with Healthy Volunteer, run by SK Life Science, Inc. at 2 sites in 2 countries.
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 9 inclusion and 19 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 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?
Pharmacodynamics using Visual Analogue Scales (VAS) (time frame: Measured for 24 hrs in each Treatment Period). 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 7 Nov 2024.