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COMPLETED
NCT05064449
PHASE1

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

Sponsor: Takeda

View on ClinicalTrials.gov

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

Interventions

DRUG

Soticlestat

Soticlestat tablets.

DRUG

Itraconazole

Itraconazole oral solution.

DRUG

Mefenamic acid

Mefenamic acid capsule.

Locations (1)

Celerion

Lincoln, Nebraska, United States