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.
The drug being tested in this study is called soticlestat (TAK-935). The study will assess the bioequivalence, effect of food and tablet crushing, safety and tolerability following single oral dose of 3 different soticlestat oral tablet formulations in healthy participants. The study will enroll approximately 96 participants. This study will be conducted in two parts (Part A and Part B) having 6 treatment sequences each. Participants will be randomly assigned (by chance, like flipping a coin) to one of the study parts as per treatment sequence: * Part A, Sequence 1: Treatment A + Treatment B + Treatment C * Part A, Sequence 2: Treatment A + Treatment C + Treatment B * Part A, Sequence 3: Treatment B + Treatment A + Treatment C * Part A, Sequence 4: Treatment B + Treatment C + Treatment A * Part A, Sequence 5: Treatment C + Treatment A + Treatment B * Part A, Sequence 6: Treatment C + Treatment B + Treatment A * Part B, Sequence 1: Treatment D + Treatment E + Treatment F * Part B, Sequence 2: Treatment D + Treatment F + Treatment E * Part B, Sequence 3: Treatment E + Treatment D + Treatment F * Part B, Sequence 4: Treatment E + Treatment F + Treatment D * Part B, Sequence 5: Treatment F + Treatment D + Treatment E * Part B, Sequence 6: Treatment F + Treatment E + Treatment D This single center trial will be conducted in the United States. The overall duration of the study is approximately 51 days. Participants will be followed up for 14 days after the last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
96
Soticlestat T4 tablets.
Soticlestat T3 mini-tablets.
Soticlestat commercial tablets.
Celerion
Tempe, Arizona, United States
Cmax: Maximum Observed Plasma Concentration for Soticlestat
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat
Time frame: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: From screening up to 14 days after the last dose of soticlestat (Day 51)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.