Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Treatment A - 400 mg Fasting; Treatment B - 400 mg Fed; Treatment C - 200 mg Fed
Intervention description: Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions; Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal; Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics

Summary:

      All participants in this study are healthy volunteers.

      Throughout the study, healthy volunteers will have physical exams, electrocardiograms and
      clinical laboratory tests. The study staff will keep track of symptoms, diet, and what
      medications they are taking.

      Each participant will get all three treatments (A, B and C). Only the order in which they
      receive them will be different.

      There are six groups based on the order: ABC, ACB, BAC, BCA, CAB, or CBA. Participants have
      an equal chance of being assigned to any of these groups.

      For each treatment period, participants will:

        -  fast overnight

        -  receive the assigned treatment with or without food

        -  have a small tube of blood drawn prior to treatment

        -  after dosing, additional blood samples will be drawn at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4,
           4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and
           144 hours

        -  have a break from treatment for 6 days between each treatment period

      All participants must reside in the clinic for a total of 20 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is healthy at screening visit

          -  Is not pregnant or lactating

          -  Is surgically or naturally unable to reproduce, or agrees to remain sexually abstinent
             or to use double barrier methods of contraception from check-in until 90 days after
             the final dose of pexidartinib

          -  Has a Body Mass Index (BMI) of 18-30 kg/m^2, inclusive

          -  Has negative test results for protocol-defined drugs and diseases at screening and/or
             check-in

          -  Is willing to avoid food or beverages before check-in until the end of the study:

               1. containing caffeine/xanthine or alcohol from 48 hours before check-in

               2. containing grapefruit or Seville oranges 6 days before check-in

        Exclusion Criteria:

          -  Per protocol or in the opinion of the investigator at screening and/or check-in, has
             something that would preclude participation:

               1. has a clinically significant disorder, disease or lab value

               2. consumes a prohibited drug, drink or food

               3. is unable to consume the standard meal

          -  Is an employee of the clinic or their family member