drugset / Trial / NCT03901313

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

NCT03901313

Phase 1 Completed 24 enrolled Daiichi Sankyo
RandomizedSequentialOpen-labelBasic science

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.

Timeline

Start
2019-04-01
Primary completion
2019-05-08
Completion
2019-05-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Pexidartinib Small molecule 200 mg Oral
Subject Pexidartinib Small molecule 400 mg Oral

Indications

No indication recorded.