At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 100 enrolled
Drug / intervention
Soticlestat 300 mg +4 moredrug
Likely dose
Soticlestat 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Soticlestat 300 mg, Soticlestat 600 mg, and 3 other interventions for Healthy Volunteers. Completed, enrolled 100 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedNov 2022
Enrollment StartNov 2022
Primary CompletionJun 2023
Study CompletionJul 2023
TodayJul 2026
First PostedNov 2, 2022
Enrollment StartNov 15, 2022
Primary CompletionJun 29, 2023
Study CompletionJul 7, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.7 years ago
Interventions
Soticlestat 300 mgdrug
Administered orally.
Soticlestat 600 mgdrug
Administered orally.
Soticlestat 900 mgdrug
Administered orally.
Alprazolamdrug
Administered orally.
Placebodrug
Administered orally.