NCT05309902

A Study of Soticlestat in Healthy Adults To Evaluate the Effect on QTc Interval

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Soticlestat	Soticlestat tablet.
DRUG	Placebo	Soticlestat placebo-matching tablet.
DRUG	Moxifloxacin	Moxifloxacin over-encapsulated tablet.
DRUG	Placebo	Moxifloxacin placebo-matching capsule.

Timeline

• Start date: 2022-10-11
• Primary completion: 2022-12-06
• Completion: 2022-12-06
• First posted: 2022-04-04
• Last updated: 2022-11-14

Regulatory

• FDA-regulated drug study