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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Open-Label, Randomized, 3-Period Crossover Study to Assess the Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901313
• Other study ID #: PL3397-A-U128
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2019
• Est. completion date: May 22, 2019

Study information

• Verified date: April 2020
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 22, 2019
• Est. primary completion date: May 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Treatment A - 400 mg Fasting
Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions
• 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
• 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

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentration in Plasma (Cmax) of Pexidartinib	Mean Cmax of pexidartinib is calculated for each treatment period	Baseline, 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 postdose
Primary	Time to Cmax (Tmax)	Median Tmax of pexidartinib is calculated for each treatment period	Baseline, 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 postdose
Primary	Area Under the Concentration-time Curve From Time of Dosing to Last Measurable Concentration (AUClast) and to Infinity (AUCinf)	Mean AUClast and AUCinf for pexidartinib are calculated for each treatment period	Baseline, 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 postdose
Primary	Terminal Half-life (t1/2)	Mean t1/2 for pexidartinib is calculated for each treatment period	Baseline, 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 postdose