A Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765

NCT01820936 ↗

Phase 1 Completed 52 enrolled Janssen Research & Development, LLC Pharmacyclics LLC. · collab

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to compare the effect of food and two modified fasting regimens on the pharmacokinetics (study of what the body does to a drug) of PCI-32765 in healthy adult participants.

Timeline

Start: 2013-03
Primary completion: 2013-06
Completion: 2013-06

Publications

de Jong J, Sukbuntherng J, Skee D, Murphy J, O'Brien S, Byrd JC, James D, Hellemans P, Loury DJ, Jiao J, Chauhan V, Mannaert E. The effect of food on the pharmacokinetics of oral ibrutinib in healthy participants and patients with chronic lymphocytic leukemia. Cancer Chemother Pharmacol. 2015 May;75(5):907-16. doi: 10.1007/s00280-015-2708-9. Epub 2015 Feb 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibrutinib	Small molecule	420 mg	Oral
Subject	Ibrutinib	Small molecule	840 mg	Oral

Indications

No indication recorded.