A Study to Assess the Effect of Rifampin on the Pharmacokinetics of PCI-32765 in Healthy Participants

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01763021

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the potential effects of rifampin on the pharmacokinetics (how the drug concentrations change over time) of PCI-32765 in healthy participants.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: PCI-32765 Drug: Rifampin	Phase 1

Detailed Description

This is an open-label (all people know the identity of the intervention), single center (study conducted at one site), sequential study (it is a design in a single group of participants are administered one or more study medication in a sequence) to evaluate the potential effects of rifampin on the pharmacokinetics of PCI-32765 in healthy participants.The study consists of 3 phases: screening phase (21 days prior to first dose of study medication), treatment phase (14 days), and a follow up phase (10 to 12 days after the last dose of study medication). In the treatment phase, a single dose of PCI-32765 560 mg will be administered orally on Day 1 and Day 11. Rifampin 600 mg (2 X 300 mg) will be administered orally on Days 4 to 13; followed by a single dose of PCI-32765 on Day 11. Follow up will be continued until Day 14. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. The duration of the study will be approximately for 45 days.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Sequential Design Study to Assess the Effect of Rifampin on the Pharmacokinetics of PCI-32765 in Healthy Subjects

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PCI-32765 + Rifampin Participants will recieve a single oral dose of PCI-32765 560 mg on Day 1 and Day 11 along with rifampin; and rifampin 600 mg from Day 4 to Day 13.	Drug: PCI-32765 PCI-32765 will be administered as a single oral dose of PCI-32765 560 mg on Day 1 and Day 11 Drug: Rifampin Rifampin 600 mg (2 X 300 mg) daily dose will be administered orally from Day 4 to Day 13 and on Day 11 along with PCI-32765.

Arm

Intervention/Treatment

Experimental: PCI-32765 + Rifampin

Participants will recieve a single oral dose of PCI-32765 560 mg on Day 1 and Day 11 along with rifampin; and rifampin 600 mg from Day 4 to Day 13.

Drug: PCI-32765

PCI-32765 will be administered as a single oral dose of PCI-32765 560 mg on Day 1 and Day 11

Drug: Rifampin

Rifampin 600 mg (2 X 300 mg) daily dose will be administered orally from Day 4 to Day 13 and on Day 11 along with PCI-32765.

Outcome Measures

Primary Outcome Measures

Maximum observed plasma concentration of PCI-32765 [Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14]
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of PCI-32765 [Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14]
Area under the plasma concentration-time curve from time 0 to infinite time of PCI-32765 [Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14]

Secondary Outcome Measures

Obsreved plasma concentrations of metabolite PCI-45227 [Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14]
Number of participants with adverse events [up to 45 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participants should be healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis performed at screening
Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

Participants with medically significant cardiac disease, hematologic, lipid abnormalities, significant pulmonary disease (bronchospastic respiratory), diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease and infectious disease
Abnormal clinical laboratory and physical examination and vital signs
Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 3 days before the first dose of the study drug is scheduled
Positive to human immunodeficiency virus-type 1 (HIV-1) or HIV-2 test and hepatitis A, B or C infection at screening