A Study to Assess the Absolute Bioavailability of Oral PCI-32765 and the Effect of Grapefruit Juice on the Bioavailability of PCI-32765 in Healthy Participants

Phase 1 Completed 8 enrolled Janssen Research & Development, LLC Pharmacyclics LLC. · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the absolute bioavailability of oral PCI-32765 and the effect of grapefruit juice on the absorption of PCI-32765 in healthy adult participants.

Timeline

Start: 2013-06
Primary completion: 2013-08
Completion: 2013-08

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	100 ug	Oral
Subject	Ibrutinib	Small molecule	140 mg	Oral
Subject	Ibrutinib	Small molecule	560 mg	Oral

Indications

No indication recorded.