Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Treatment A - 400 mg FastingDrug: Treatment B - 400 mg FedDrug: Treatment C - 200 mg Fed
- Registration Number
- NCT03901313
- Lead Sponsor
- Daiichi Sankyo
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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Is healthy at screening visit
-
Is not pregnant or lactating
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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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Sequence ABC Treatment B - 400 mg Fed 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 Sequence ABC Treatment C - 200 mg Fed 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 Sequence ACB Treatment A - 400 mg Fasting 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 Sequence BAC Treatment C - 200 mg Fed 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 Sequence BCA Treatment A - 400 mg Fasting 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 Sequence BAC Treatment B - 400 mg Fed 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 Sequence BCA Treatment B - 400 mg Fed 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 Sequence CBA Treatment B - 400 mg Fed 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 Sequence BCA Treatment C - 200 mg Fed 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 Sequence CAB Treatment C - 200 mg Fed 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 Sequence BAC Treatment A - 400 mg Fasting 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 Sequence ABC Treatment A - 400 mg Fasting 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 Sequence ACB Treatment B - 400 mg Fed 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 Sequence ACB Treatment C - 200 mg Fed 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 Sequence CBA Treatment A - 400 mg Fasting 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 Sequence CAB Treatment A - 400 mg Fasting 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 Sequence CBA Treatment C - 200 mg Fed 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 Sequence CAB Treatment B - 400 mg Fed 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
- Primary Outcome Measures
Name Time Method Terminal Half-life (t1/2) 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
Maximum Observed Concentration in Plasma (Cmax) of Pexidartinib 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
Time to Cmax (Tmax) 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
Area Under the Concentration-time Curve From Time of Dosing to Last Measurable Concentration (AUClast) and to Infinity (AUCinf) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Worldwide Clinical Trials
🇺🇸San Antonio, Texas, United States