Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of Soticlestat Tablets in Healthy Adults
Sponsor: Takeda
Summary
The main aim is to see how soticlestat tablets of different strengths work and to compare how it works alone in contrast to administration along with food. In the study will be 2 groups of participants (part A and part B). Participants in part A will receive 300 mg of soticlestat administered in different kind of tablets (regular tablets, mini-tablets, commercial tablets) and participant in part B will also receive 300 mg of soticlestat in tablets but with food and crushed tablets with applesauce. Participants will complete several assessments including clinical laboratory evaluations, physical examinations, Columbia-Suicide Severity Rating Scale (C-SSRS) assessment, electrocardiographs (ECGs), and vital signs.
Official title: A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of Soticlestat Oral Tablet Formulations and the Effect of Food and Tablet Crushing on the Pharmacokinetics of Soticlestat in Healthy Adult Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2022-03-11
Completion Date
2022-06-02
Last Updated
2026-09-10
Healthy Volunteers
Yes
Conditions
Interventions
Soticlestat
Soticlestat T4 tablets.
Soticlestat
Soticlestat T3 mini-tablets.
Soticlestat
Soticlestat commercial tablets.
Locations (1)
Celerion
Tempe, Arizona, United States