A Study of Soticlestat and Rifampin in Healthy Adults
Condition: Healthy Volunteers
Intervention: Soticlestat; Rifampin
Intervention description: Soticlestat tablets.; Rifampin capsules.
Intervention MeSH terms: Rifampin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

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.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy, adult, male or female of non-childbearing potential, 18-55 years of age,
             inclusive, at screening.

          2. Has body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to
             (<=) 32.0 kilogram per square meter (kg/m^2) at screening.

          3. Continuous non-smoker who has not used nicotine-containing products for at least 90
             days prior to the first dosing.

          4. Able to swallow multiple tablets/capsules.

        Exclusion criteria:

          1. Has history of any illness that, in the opinion of the Investigator or designee, might
             confound the results of the study or poses an additional risk to the participant by
             their participation in the study.

          2. Any positive responses on the C-SSRS that in the clinical judgment of the Investigator
             has a risk of suicide or has made a suicide attempt in the previous 12 months prior to
             the first dosing.

          3. Unable to refrain from or anticipates the use of:

               -  Any drug, including prescription and non-prescription medications, herbal
                  remedies, or vitamin supplements within 14 days prior to the first dosing.
                  Thyroid hormone replacement medication may be permitted if the participant has
                  been on the same stable dose for the immediate 3 months prior to first dosing.

               -  Any drugs known to be significant inducers of cytochrome (CYP)3A, CYP2C19, UGT1A9
                  or UGT2B4 enzymes, and/or P-glycoprotein (P-gp), including St. John's Wort,
                  within 28 days prior to the first dosing.

             Appropriate sources (example, Flockhart TableTM) will be consulted to confirm lack of
             pharmacokinetic (PK)/pharmacodynamics interaction with study drug.

          4. History of alcohol consumption exceeding 2 standard drinks per day on average (1 glass
             is approximately equivalent to the following: beer 354 milliliter [mL]/12 ounce [oz],
             wine [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day).

          5. Consumes excessive amounts, defined as greater than 4 servings (1 serving is
             approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy drinks,
             or other caffeinated beverages per day.

          6. Has been on a diet incompatible with the on-study diet, in the opinion of the
             Investigator or designee, within the 30 days prior to the first dosing and throughout
             the study.

          7. Donation of blood or significant blood loss within 56 days prior to the first dosing.

          8. Plasma donation within 7 days prior to the first dosing.

          9. Participation in another clinical study within 30 days or 5 half-lives prior to the
             first dosing. The 30-days window or 5 half-lives will be derived from the date of the
             last blood collection or dosing, whichever is later, in the previous study to Day 1 of
             Period 1 of the current study.