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.

The primary objectives of this study are:

• To assess the effect of low-fat food on the pharmacokinetics (PK) of pexidartinib following a single oral dose of 400 mg administered in healthy subjects
• To assess the PK of pexidartinib following a single oral dose of 200 mg administered with low-fat food in healthy subjects

The secondary objective of this study is:

• To characterize the safety and tolerability of pexidartinib in healthy subjects following administration of a single oral dose of pexidartinib with low fat food and without food

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

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Adverse events were collected from study enrollment up to 28 days of administration of the last dose of study treatment.

A treatment-emergent adverse event (TEAE) was defined as an adverse event that emerged during treatment, having been absent pre-treatment, or worsened relative to the pre-treatment state.