NCT02381080View on ClinicalTrials.gov

Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

May 19, 2015

Primary Completion Date

June 24, 2016

Study Completion Date

June 24, 2016

Conditions
B-Cell Chronic Lymphocytic Leukemia
Interventions
DRUG

Ibrutinib

Ibrutinib capsule (at dose level of 140 or 420 or 560 mg) will be taken orally QD up to six, 28-days cycles.

DRUG

Erythromycin

Erythromycin 500 mg tablet will be taken orally TID (Part1 Cycle 1: on Days 5-10 and morning dose on Day 11; Part2 Cycle 1: on Days 5-17 and morning dose on Day 18).

DRUG

Voriconazole

Voriconazole 200 mg tablet will be taken orally BD (Part1 Cycle 1: on Days 19-25; Part2 Cycle 1: on Days 5-17).

Trial Locations (6)

Unknown

N/a N/a

Moscow

Petrozavodsk

Saint Petersburg

Madrid

Pamplona

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02381080 - Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy | Biotech Hunter | Biotech Hunter