A Study of Soticlestat Tablets in Healthy Adults

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID
NCT05284760
Run by
Takeda
People needed
96
Starts
2022-03-11
Expected to finish
2022-06-02
Last updated by the study team
2024-02-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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