NCT05602818

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Soticlestat 300 mg	Administered orally.
DRUG	Soticlestat 600 mg	Administered orally.
DRUG	Soticlestat 900 mg	Administered orally.
DRUG	Alprazolam	Administered orally.
DRUG	Placebo	Administered orally.

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-06-29
• Completion: 2023-07-07
• First posted: 2022-11-02
• Last updated: 2024-12-09
• Results posted: 2024-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study