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A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults
Sponsor: Takeda
Summary
The main aim of this study is to check how itraconazole and mefenamic acid affect the way soticlestat is processed by the body. The study will have 2 parts. Participants can only participate in one study part. Part 1: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving itraconazole and will stay in the clinic for 11 more days, receiving soticlestat in combination with itraconazole on one of those days. Participants will be contacted about 8 days after leaving the clinic for follow-up. Part 2: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving mefenamic acid and will stay in the clinic for 7 more days, receiving soticlestat in combination with mefenamic acid on one of those days.. Participants will be contacted about 9 days after leaving the clinic for follow-up.
Official title: A Phase 1, Open-Label Study to Evaluate the Effect of Itraconazole and Mefenamic Acid on the Single-Dose Pharmacokinetic Profile of Soticlestat in Healthy Participants
Key Details
Gender
All
Age Range
19 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2021-10-14
Completion Date
2021-11-30
Last Updated
2026-09-10
Healthy Volunteers
Yes
Conditions
Interventions
Soticlestat
Soticlestat tablets.
Itraconazole
Itraconazole oral solution.
Mefenamic acid
Mefenamic acid capsule.
Locations (1)
Celerion
Lincoln, Nebraska, United States