NCT03301207View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 20, 2017

Primary Completion Date

July 17, 2018

Study Completion Date

December 4, 2018

Conditions
Leukemia, Lymphocytic, Chronic, B-Cell
Interventions
DRUG

Ibrutinib

Ibrutinib capsule (at dose of 420 or 560 mg) will be taken orally QD.

DRUG

OC: Ethinylestradiol (EE) 30 mcg and Levonorgestrel (LN) 150 mcg

Single dose of oral contraceptives (OC) (1 tablet containing 30 mcg EE and 150 mcg LN) will be taken orally on Study Days 1 and 22.

DRUG

Bupropion

Bupropion 75 mg tablet as a part of CYP cocktail will be taken on Study Days 3 and 24.

DRUG

Midazolam

Midazolam 2 mg (1 milliliter \[mL\]) oral solution will be taken on Study Days 3 and 24 (as a part of CYP cocktail) and on Study Day 8 (alone).

Trial Locations (4)

28040

Hosp. Univ. Fund. Jimenez Diaz, Madrid

31008

Clinica Univ. de Navarra, Pamplona

30-510

Pratia MCM Krakow, Krakow

50-367

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03301207 - 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 | Biotech Hunter | Biotech Hunter