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

Takeda

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Soticlestat 600 mg; Drug: Soticlestat 300 mg; Drug: Placebo; Drug: Soticlestat 900 mg; Drug: Alprazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT05602818

TAK-935-1012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 5 patient groups, including a placebo group

Soticlestat 300 mg

Experimental group

Description:

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

Treatment:

Drug: Soticlestat 300 mg

Soticlestat 600 mg

Experimental group

Description:

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

Treatment:

Drug: Soticlestat 600 mg

Soticlestat 900 mg

Experimental group

Description:

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

Treatment:

Drug: Soticlestat 900 mg

Alprazolam 2 mg

Active Comparator group

Description:

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

Treatment:

Drug: Alprazolam

Placebo

Placebo Comparator group

Description:

Participants will receive a single oral dose of matching placebo.

Treatment:

Drug: Placebo