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Completed

NCT Number: NCT03901313

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • containing caffeine/xanthine or alcohol from 48 hours before check-in
  • 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:
  • has a clinically significant disorder, disease or lab value
  • consumes a prohibited drug, drink or food
  • is unable to consume the standard meal
  • Is an employee of the clinic or their family member

Treatment and study plan

Treatment A - 400 mg Fasting

Drug

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

Other names: Pexidartinib

Treatment B - 400 mg Fed

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

Other names: Pexidartinib

Treatment C - 200 mg Fed

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

Other names: Pexidartinib

Primary outcomes

  1. Maximum Observed Concentration in Plasma (Cmax) of Pexidartinib

    Time frame: 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

    Mean Cmax of pexidartinib is calculated for each treatment period

  2. Time to Cmax (Tmax)

    Time frame: 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

    Median Tmax of pexidartinib is calculated for each treatment period

  3. Area Under the Concentration-time Curve From Time of Dosing to Last Measurable Concentration (AUClast) and to Infinity (AUCinf)

    Time frame: 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

    Mean AUClast and AUCinf for pexidartinib are calculated for each treatment period

  4. Terminal Half-life (t1/2)

    Time frame: 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

    Mean t1/2 for pexidartinib is calculated for each treatment period

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2019
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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