NCT05098041

A Study of Soticlestat and Rifampin in Healthy Adults

A Phase 1 Open-Label Study to Evaluate the Drug-Drug Interaction of Rifampin as a Strong CYP3A Inducer on Soticlestat Pharmacokinetics in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main aim of this study is to check how rifampin affects the way soticlestat is processed by the body. Participants will be required to stay at the study clinic for 18 consecutive days. On the first full day and 15th day, participants will take a single dose of soticlestat. Rifampin will be taken each day starting on the 5th day for 13 consecutive days. Clinic staff will follow up with each participant about 15 days after the last soticlestat dose to check for any side effects.

Detailed description

The drug being tested in this study is called soticlestat (TAK-935). The study will evaluate the safety and tolerability of soticlestat when co-administered with rifampin in healthy participants. The study will enroll 14 participants. The participants will be assigned to treatment group to receive following therapies: • Soticlestat 300 milligram (mg) + Rifampin 600 mg The study will have two periods: Period 1 and Period 2. In Period 1, participants will receive soticlestat in fasted condition while in Period 2 participants will receive soticlestat along with rifampin. The data will be collected and stored in electronic case report form (eCRF). This single-center trial will be conducted in the United Kingdom. The overall study duration of the study will be approximately 58 days including 28 days screening and follow up duration. There will be a follow up contact required for all participants approximately 15 days after the last dose of soticlestat.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Soticlestat	Soticlestat tablets.
DRUG	Rifampin	Rifampin capsules.

Timeline

• Start date: 2021-11-22
• Primary completion: 2022-02-16
• Completion: 2022-03-03
• First posted: 2021-10-28
• Last updated: 2023-11-22
• Results posted: 2023-11-22

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study