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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05602818
• Other study ID #: TAK-935-1012
• Status: Completed
• Phase: Phase 1
• Start date: November 15, 2022
• Est. completion date: July 7, 2023

Study information

• Verified date: July 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 7, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Soticlestat 300 mg
Administered orally.
• Soticlestat 600 mg
Administered orally.
• Soticlestat 900 mg
Administered orally.
• Alprazolam
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
United States	Altasciences	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).

External Links

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