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

NCT ID: NCT05602818

Last Updated: 2024-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-07-07

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.

Conditions

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Healthy Volunteers

Keywords

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Drug Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Soticlestat 300 mg

Participants will receive a single oral dose of soticlestat 300 milligrams (mg).

Group Type EXPERIMENTAL

Soticlestat 300 mg

Intervention Type DRUG

Administered orally.

Soticlestat 600 mg

Participants will receive a single oral dose of soticlestat 600 mg.

Group Type EXPERIMENTAL

Soticlestat 600 mg

Intervention Type DRUG

Administered orally.

Soticlestat 900 mg

Participants will receive a single oral dose of soticlestat 900 mg.

Group Type EXPERIMENTAL

Soticlestat 900 mg

Intervention Type DRUG

Administered orally.

Alprazolam 2 mg

Participants will receive a single oral dose of over encapsulated alprazolam 2 mg.

Group Type ACTIVE_COMPARATOR

Alprazolam

Intervention Type DRUG

Administered orally.

Placebo

Participants will receive a single oral dose of matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Interventions

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Soticlestat 300 mg

Administered orally.

Intervention Type DRUG

Soticlestat 600 mg

Administered orally.

Intervention Type DRUG

Soticlestat 900 mg

Administered orally.

Intervention Type DRUG

Alprazolam

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy as determined by the investigator.
2. 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.
3. 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

1. Self-reported history of drug or alcohol dependence (within the past 1 year, except caffeine or nicotine, prior to the screening visit).
2. Positive alcohol breathalyzer or urine drug screen (UDS) for substances of abuse at admission, excluding tetrahydrocannabinol (THC).
3. Heavy smoker or user of other types of nicotine products (greater than \[\>\] 20 cigarettes equivalent per day).
4. Unable to abstain from smoking for at least 2 hours before and at least 8 hours after dosing.
5. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Altasciences

Overland Park, Kansas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://classic.clinicaltrials.gov/ct2/bye/kQoPWwoRrXS90dhzuQ7gkdoPSQ7GvwSxWB7mz6hjuBc9mX-gWi7PxX7PzihGedY9kRh8EB76k6NjLK7jWKCtOscz5PNzvihHSsD8LVp8SRzP3DSWxRF8mRCtaRp8SRp8LPt/3HhqJdcyWB7zunhLZwN8JQ7xNd-ymB1PedcOJdcOJihkznogWi7PxXY30dhz0QS3l61yzXc9unoPlQ1RJdhzuQSO

To obtain more information on the study, click here/on this link.

Other Identifiers

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TAK-935-1012

Identifier Type: -

Identifier Source: org_study_id