Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers

NCT ID: NCT03901313

Last Updated: 2020-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-05-22

Brief 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.

Detailed Description

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sequence ABC

Healthy volunteers will receive Treatments A, then B, and then C, with a 6-day washout between treatments, during a stay at the clinic of 20 days

Group Type: EXPERIMENTAL

Treatment A - 400 mg Fasting

Intervention Type: DRUG

Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions

Treatment B - 400 mg Fed

Intervention Type: DRUG

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

Treatment C - 200 mg Fed

Intervention Type: DRUG

Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal

Sequence ACB

Healthy volunteers will receive Treatments A, then C, and then B, with a 6-day washout between treatments, during a stay at the clinic of 20 days

Group Type: EXPERIMENTAL

Treatment A - 400 mg Fasting

Intervention Type: DRUG

Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions

Treatment B - 400 mg Fed

Intervention Type: DRUG

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

Treatment C - 200 mg Fed

Intervention Type: DRUG

Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal

Sequence BAC

Healthy volunteers will receive Treatments B, then A, and then C, with a 6-day washout between treatments, during a stay at the clinic of 20 days

Group Type: EXPERIMENTAL

Treatment A - 400 mg Fasting

Intervention Type: DRUG

Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions

Treatment B - 400 mg Fed

Intervention Type: DRUG

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

Treatment C - 200 mg Fed

Intervention Type: DRUG

Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal

Sequence BCA

Healthy volunteers will receive Treatments B, then C, and then A, with a 6-day washout between treatments, during a stay at the clinic of 20 days

Group Type: EXPERIMENTAL

Treatment A - 400 mg Fasting

Intervention Type: DRUG

Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions

Treatment B - 400 mg Fed

Intervention Type: DRUG

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

Treatment C - 200 mg Fed

Intervention Type: DRUG

Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal

Sequence CAB

Healthy volunteers will receive Treatments C, then A, and then B, with a 6-day washout between treatments, during a stay at the clinic of 20 days

Group Type: EXPERIMENTAL

Treatment A - 400 mg Fasting

Intervention Type: DRUG

Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions

Treatment B - 400 mg Fed

Intervention Type: DRUG

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

Treatment C - 200 mg Fed

Intervention Type: DRUG

Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal

Sequence CBA

Healthy volunteers will receive Treatments C, then B, and then A, with a 6-day washout between treatments, during a stay at the clinic of 20 days

Group Type: EXPERIMENTAL

Treatment A - 400 mg Fasting

Intervention Type: DRUG

Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions

Treatment B - 400 mg Fed

Intervention Type: DRUG

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

Treatment C - 200 mg Fed

Intervention Type: DRUG

Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal

Interventions

Treatment A - 400 mg Fasting

Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions

Intervention Type: DRUG

Treatment B - 400 mg Fed

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

Intervention Type: DRUG

Treatment C - 200 mg Fed

Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal

Intervention Type: DRUG

Other Intervention Names

Pexidartinib; Pexidartinib; Pexidartinib

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daiichi Sankyo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Leader

Role: STUDY_DIRECTOR

Daiichi Sankyo

Locations

Worldwide Clinical Trials

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PL3397-A-U128

Identifier Type: -

Identifier Source: org_study_id