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

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Soticlestat 300 mg
Drug: Soticlestat 600 mg
Drug: Soticlestat 900 mg
Drug: Alprazolam
Drug: Placebo

Registration Number: NCT05602818

Lead Sponsor: Takeda

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Soticlestat 300 mg	Soticlestat 300 mg	Participants will receive a single oral dose of soticlestat 300 milligrams (mg).
Soticlestat 600 mg	Soticlestat 600 mg	Participants will receive a single oral dose of soticlestat 600 mg.
Soticlestat 900 mg	Soticlestat 900 mg	Participants will receive a single oral dose of soticlestat 900 mg.
Alprazolam 2 mg	Alprazolam	Participants will receive a single oral dose of over encapsulated alprazolam 2 mg.
Placebo	Placebo	Participants will receive a single oral dose of matching placebo.

Primary Outcome Measures

Name	Time	Method
Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS)	Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose	Drug liking ("at this moment") assessed how much a participant likes or dislikes a drug effect at the time the question was being asked. It was scored using a 0 to 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates stronger liking.

Secondary Outcome Measures

Name	Time	Method
Treatment Phase: Overall Drug Liking (Emax) Assessed Using Bipolar VAS	Day 1 of each Treatment Period: 12 and 24 hours post-dose	Overall drug liking assesses participant's overall experience with the drug by assessing the participant's overall liking for the drug. It was scored using a 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates better liking. The "overall drug liking" was an independent measure and not an "at this moment" assessment.
Treatment Phase: Take Drug Again (Emax) Assessed "Overall" by Using Bipolar VAS	Day 1 of each Treatment Period: 12 and 24 hours post-dose	Take drug again was a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It was scored using a 0 to 100-point bipolar VAS, where 0: Definitely not, 50: Neutral, 100: Definitely so. A higher score indicates stronger desire.
Treatment Phase: Bad Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS	Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose	Bad drug effects assessed the bad effect of drug experienced by the participant at the time the question is being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger bad drug effect.
Treatment Phase: Good Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS	Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose	Good drug effects assessed the good effect of drug experienced by the participant at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and range from 0 (Not at all) to 100 (extremely). A higher score indicated a stronger good drug effect.
Treatment Phase: High (Emax) Assessed "At This Moment" by Using Unipolar VAS	Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose	High assessed the degree that a participant feels a good effect (that is, euphoria) at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger high effect.
Treatment Phase: Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)	From start of study drug administration (Day 1) up to Day 37	An AE was 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 was defined as an adverse event that started or worsened during or after the first dose of study drug.