Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 9:54 AM
Study NCT ID:
NCT05284760
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Soticlestat Tablets in Healthy Adults
Sponsor:
Takeda
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: