Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT05309902
Status:
WITHDRAWN
Last Update Posted:
2022-11-14
First Post:
2022-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Soticlestat in Healthy Adults To Evaluate the Effect on QTc Interval
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Phase 1, Double-Blinded, Placebo- and Active-Controlled, Randomized Study to Investigate the Potential of Soticlestat to Prolong the QTc Interval in Healthy Adult Participants
Status:
WITHDRAWN
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study not needed
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 if soticlestat has any effect in the heart rate.
Participants will receive 4 doses of soticlestat in tablets and will complete some assessment which include to record activity of the heart and collection of blood samples.
Then, the clinic will contact the participants 14 days after their final dose of soticlestat to check if they have any health problems.
Participants will receive 4 doses of soticlestat in tablets and will complete some assessment which include to record activity of the heart and collection of blood samples.
Then, the clinic will contact the participants 14 days after their final dose of soticlestat to check if they have any health problems.
Detailed Description:
The drug being tested in this study is called soticlestat. Soticlestat is being tested in healthy participants for the purpose of this study. This study will assess the effect of single-dose of soticlestat on the heart rate (QTc prolongation). The study will enroll approximately 60 participants.
Participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 4 treatments sequences.
* Sequence 1: (Regimen A+ Regimen B + Regimen C + Regimen D)
* Sequence 2: (Regimen B+ Regimen D + Regimen A + Regimen C)
* Sequence 3: (Regimen C+ Regimen A + Regimen D + Regimen B)
* Sequence 4: (Regimen D+ Regimen C + Regimen B + Regimen A)
All participants will receive all 4 treatment regimens. Treatment order will remain undisclosed to the participants and study doctor (unless there is an urgent medical need). This is a single-center trial. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 63 days including screening period and follow-up period.
Participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 4 treatments sequences.
* Sequence 1: (Regimen A+ Regimen B + Regimen C + Regimen D)
* Sequence 2: (Regimen B+ Regimen D + Regimen A + Regimen C)
* Sequence 3: (Regimen C+ Regimen A + Regimen D + Regimen B)
* Sequence 4: (Regimen D+ Regimen C + Regimen B + Regimen A)
All participants will receive all 4 treatment regimens. Treatment order will remain undisclosed to the participants and study doctor (unless there is an urgent medical need). This is a single-center trial. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 63 days including screening period and follow-up period.
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?: