A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience

Study Overview
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Brief Summary
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The main aim is to evaluate the relative abuse potential of soticlestat in healthy adults who has used central nervous system (CNS) depressants for recreational nontherapeutic reasons.

Detailed Description
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The drug being tested in this study is called soticlestat. Soticlestat is being tested in healthy participants. This study will assess the relative abuse potential of soticlestat compared to alprazolam and placebo in healthy adult, nondependent recreational drug users with CNS depressant experience. The study will enroll approximately 110 participants. Participants will be randomly (by chance, like flipping a coin) assigned to treatments of the study. Treatment order will remain undisclosed to the participants and study doctor (unless there is an urgent medical need). This single center trial will be conducted in the United States. Participants will be followed up for up to 7 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 11 weeks.

Official Title
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A Phase 1, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 5-Way Crossover Study Evaluating the Abuse Potential of Soticlestat (TAK-935) in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System Depressant Experience

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Soticlestat 300 mg
* Drug: Soticlestat 600 mg
* Drug: Soticlestat 900 mg
* Drug: Alprazolam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Healthy as determined by the investigator. Current CNS depressant user who has used CNS depressants (example, benzodiazepines, barbiturates, zolpidem, eszopiclone, zopiclone, propofol/fospropofol, gamma-hydroxybutyrate) for recreational, nontherapeutic reasons at least 10 times in their lifetime and at least once in the 12 weeks prior to screening. Participant must also have recreational experience with at least 1 other drug class associated with abuse (example, opioids, stimulants, cannabinoids, hallucinogens, dissociatives) at least 10 times in their lifetime. Body mass index (BMI) of 18.5 to 35.0 kilogram per square meter (kg/m^2), inclusive, and a minimum body weight of 50.0 Kilogram (kg) at screening. Exclusion Criteria Self-reported history of drug or alcohol dependence (within the past 1 year, except caffeine or nicotine, prior to the screening visit). Positive alcohol breathalyzer or urine drug screen (UDS) for substances of abuse at admission, excluding tetrahydrocannabinol (THC). Heavy smoker or user of other types of nicotine products (greater than [>] 20 cigarettes equivalent per day). Unable to abstain from smoking for at least 2 hours before and at least 8 hours after dosing. Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soticlestat 300 mg<br>Participants will receive a single oral dose of soticlestat 300 milligrams (mg). | Drug: Soticlestat 300 mg<br>* Administered orally.<br>|
| Experimental: Soticlestat 600 mg<br>Participants will receive a single oral dose of soticlestat 600 mg. | Drug: Soticlestat 600 mg<br>* Administered orally.<br>|
| Experimental: Soticlestat 900 mg<br>Participants will receive a single oral dose of soticlestat 900 mg. | Drug: Soticlestat 900 mg<br>* Administered orally.<br>|
| Active Comparator: Alprazolam 2 mg<br>Participants will receive a single oral dose of over encapsulated alprazolam 2 mg. | Drug: Alprazolam<br>* Administered orally.<br>|
| Placebo Comparator: Placebo<br>Participants will receive a single oral dose of matching placebo. | Drug: Placebo<br>* Administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emax: Maximum Effect for Drug Liking as Assessed Using Bipolar Visual Analogue Scale (VAS). | Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question is being asked. It is scored using a 100-point bipolar VAS, where 0=Strong disliking, 50=Neither like nor dislike (neutral point), 100=Strong liking. | Up to 24 hours post dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Drug Liking (Emax) Assessed Using Bipolar VAS. | Overall drug liking assesses how much a participant likes or dislikes the drug at the time the question is being asked. It is scored using a 100-point bipolar VAS, where 0=Strong disliking, 50=Neither like nor dislike (neutral point), 100=Strong liking. | Up to 24 hours post dose. | 
| Take Drug Again (Emax) Assessed Overall by Using Bipolar VAS | Take drug again is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is scored using a 100-point bipolar VAS, where 0=Definitely not, 50=neutral, 100=Definitely so. | Up to 24 hours post dose. | 
| Bad Drug Effects (Emax) Assessed at this moment by Using Unipolar VAS | Bad drug effects assess the bad effect of drug experienced by the participant at the time the question is being asked. It is scored using a 100-point unipolar VAS, where responses are unidirectional and range from 0 (Not at all) to 100 (Extremely). | Up to 24 hours post dose. | 
| Good Drug effects (Emax) Assessed at this moment by Using Unipolar VAS | Good drug effects assess the good effect of drug experienced by the participant at the time the question is being asked. It is scored using a 100-point unipolar VAS, where responses are unidirectional and range from 0 (Not at all) to 100 (extremely). | Up to 24 hours post dose. | 
| High (Emax) Assessed at this moment by Using Unipolar VAS | High assesses the degree that a participant feels a good effect (that is, euphoria) at the time the question is being asked. It is scored using a 100-point unipolar VAS, where responses are unidirectional and range from 0 (Not at all) to 100 (Extremely). | Up to 24 hours post dose. | 
| Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. | Day 1 up to 7 days after last dose of study drug (up to Day 40). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy