A Crossover Study to Evaluate the Bioavailability of Ibrutinib Suspension and Sprinkle Formulations Compared to Capsules in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Healthy
Interventions
DRUG

Ibrutinib (Treatment A) [Reference]

Participants will receive Ibrutinib 560 milligram (mg) (4\*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.

DRUG

Ibrutinib (Treatment B)

Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.

DRUG

Ibrutinib (Treatment C)

Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.

DRUG

Ibrutinib (Treatment D)

Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment D under fasted conditions in one of the treatment periods.

DRUG

Ibrutinib (Treatment E)

Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment E under fed (high-fat) conditions in one of the treatment periods.

DRUG

Ibrutinib (Treatment F)

Participants will receive Ibrutinib 560 mg sprinkle capsule granules suspended in water as Treatment F under fasted conditions in one of the treatment periods.

Trial Locations (1)

Unknown

Antwerp

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02390609 - A Crossover Study to Evaluate the Bioavailability of Ibrutinib Suspension and Sprinkle Formulations Compared to Capsules in Healthy Adults | Biotech Hunter | Biotech Hunter