drugset / Trial / NCT05064449

A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults

NCT05064449

Phase 1 Completed 28 enrolled Takeda
Non-randomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2021-10-14
Primary completion
2021-11-21
Completion
2021-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule 200 mg Oral
Subject Mefenamic acid Small molecule 250 mg Oral
Subject Soticlestat Small molecule 300 mg Oral

Indications

No indication recorded.