A Study to Evaluate the Effects of Ibrutinib on Cardiac Repolarization in Healthy Participants

Phase 1 Completed 28 enrolled Janssen Research & Development, LLC

RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to assess the safety and tolerability of ibrutinib, to compare the pharmacokinetics of ibrutinib after single oral administration of 840 mg and 1680 mg and to assess the effects of a single dose of ibrutinib on QT/QTc intervals and electrocardiogram (ECG) in healthy adults.

Timeline

Start: 2014-10
Primary completion: 2015-04
Completion: 2015-05

Outcome

Met primary endpoint

paper The upper bounds of the 90% CIs for the mean difference in change from baseline in QTc between ibrutinib and placebo were < 10 ms at all timepoints and at PMID 29080970 ↗

paper Therapeutic and supratherapeutic concentrations of ibrutinib do not prolong the QTc interval. PMID 29080970 ↗

Publications

de Jong J, Hellemans P, Jiao JJ, Huang Y, Mesens S, Sukbuntherng J, Ouellet D. Ibrutinib does not prolong the corrected QT interval in healthy subjects: results from a thorough QT study. Cancer Chemother Pharmacol. 2017 Dec;80(6):1227-1237. doi: 10.1007/s00280-017-3471-x. Epub 2017 Oct 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibrutinib	Small molecule	840 mg	Oral
Subject	Ibrutinib	Small molecule	1680 mg	Oral
Subject	Moxifloxacin	Small molecule	400 mg	Oral

Indications

No indication recorded.