CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
Soticlestat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05098041
NCT05098041Phase 1Completed
CompareCT.gov

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

Takeda·interventional·Posted Oct 28, 2021·Updated Nov 22, 2023

In Brief

A Phase 1 clinical trial evaluating Soticlestat and Rifampin for Healthy Volunteers. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedOct 28, 2021
Enrollment StartNov 22, 2021
Primary CompletionFeb 16, 2022
Study CompletionMar 3, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.7 years ago

Interventions

Soticlestatdrug

Soticlestat tablets.

Rifampindrug

Rifampin capsules.