NCT03901313

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Treatment A - 400 mg Fasting	Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions
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
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

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-05-08
• Completion: 2019-05-22
• First posted: 2019-04-03
• Last updated: 2020-05-11
• Results posted: 2020-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study