Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers
Status:
Completed
Trial end date:
2019-05-22
Target enrollment:
Participant gender:
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.