A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

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.
    

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 either itraconazole or
      mefenamic acid in healthy participants.

      The study will be conducted in 2 parts: Part 1 (drug-drug interaction [DDI] with
      itraconazole), Part 2 (DDI with mefenamic acid). The study will enroll approximately 28
      participants. Participants will be enrolled into two parts (Part 1 and Part 2) to receive
      soticlestat along with adjunctive therapy itraconazole and mefenamic acid as:

        -  Part 1: Soticlestat 300 mg + Itraconazole 200 mg

        -  Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg (first dose only) and 250 mg
           (subsequent doses)

      Both Parts 1 and 2 will have two period (Periods 1 and 2). In Period 1, participants will
      receive only soticlestat (study drug) and in Period 2, participants will receive study drug
      along with either itraconazole or mefenamic acid depending upon in which part they are in.
      The data will be collected and stored in electronic case report form (eCRF).

      This single-center trial will be conducted in the United States. The overall duration of the
      study is approximately 52 days for participants in Part 1 (includes screening and follow-up),
      but 48 days for participants in Part 2 (including screening and follow-up). There will be
      follow up for all participants approximately 15 days after the last dose of soticlestat in
      each study part.
    

Intervention name(s): Soticlestat; Itraconazole; Mefenamic acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Soticlestat tablets.; Itraconazole oral solution.; Mefenamic acid capsule.
Other intervention name(s): TAK-935
Intervention MeSH terms: Itraconazole; Mefenamic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug Therapy