A Study to Evaluate the Effect of Ibrutinib on the Pharmacokinetics of Oral Contraceptives, CYP2B6, and CYP3A4 Substrates in Female Participants With B Cell Malignancy

Summary

The main purpose of this study is to evaluate the effects of repeat dosing of ibrutinib on the single-dose pharmacokinetics (PK) of oral contraceptives (OC - ethinylestradiol \[EE\] and levonorgestrel \[LN\]), the cytochrome P450 (CYP)2B6 probe bupropion and the CYP3A4 probe midazolam; and to evaluate the effects of single-dose ibrutinib on the single-dose PK of the CYP3A4 probe midazolam in female participants with B cell malignancy.

Timeline

Start

2017-10-20

Primary completion

2018-07-17

Completion

2018-12-04

Publications

• de Jong J, Mitselos A, Jurczak W, Cordoba R, Panizo C, Wrobel T, Dlugosz-Danecka M, Jiao J, Sukbuntherng J, Ouellet D, Hellemans P. Ibrutinib does not have clinically relevant interactions with oral contraceptives or substrates of CYP3A and CYP2B6. Pharmacol Res Perspect. 2020 Oct;8(5):e00649. doi: 10.1002/prp2.649.

Drugs

Indications