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COMPLETED
NCT05284760
PHASE1

A Study of Soticlestat Tablets in Healthy Adults

Sponsor: Takeda

View on ClinicalTrials.gov

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

Interventions

DRUG

Soticlestat

Soticlestat T4 tablets.

DRUG

Soticlestat

Soticlestat T3 mini-tablets.

DRUG

Soticlestat

Soticlestat commercial tablets.

Locations (1)

Celerion

Tempe, Arizona, United States