drugset / Trial / NCT05284760
A Study of Soticlestat Tablets in Healthy Adults
RandomizedCrossoverOpen-labelOther
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.
Timeline
- Start
- 2022-03-11
- Primary completion
- 2022-05-22
- Completion
- 2022-06-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Soticlestat | Small molecule | 300 mg | Oral |
Indications
No indication recorded.