Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT05284760
Brief 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.
Detailed Description:
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:
NCT05284760
Study Brief:
Protocol Section:
NCT05284760