Overview

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

Status:
Completed

Trial end date:
2018-12-04

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Janssen Research & Development, LLC

Treatments:

Bupropion
Contraceptive Agents
Contraceptives, Oral
Ethinyl Estradiol
Ethinyl estradiol, levonorgestrel drug combination
Levonorgestrel
Midazolam