A Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Healthy Volunteers
Interventions
DRUG

Sequence 1: PCI-32765

Period 1 = Treatment D, Period 2 = Treatment C, Period 3 = Treatment A, Period 4 = Treatment B

DRUG

Sequence 2: PCI-32765

Period 1 = Treatment A, Period 2 = Treatment D, Period 3 = Treatment B, Period 4 = Treatment C

DRUG

Sequence 3: PCI-32765

Period 1 = Treatment B, Period 2 = Treatment A, Period 3 = Treatment C, Period 4 = Treatment D

DRUG

Sequence 4: PCI-32765

Period 1 = Treatment C, Period 2 = Treatment B, Period 3 = Treatment D, Period 4 = Treatment A

DRUG

Sequence 5: PCI-32765

After completion of the 4-way crossover, an additional separate cohort of 8 subjects were enrolled. These subjects participated in 1 treatment period to document safety and PK

Trial Locations (1)

Unknown

Neptune City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY