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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PCI-32765

Intervention Type DRUG

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

Rifampin

Intervention Type DRUG

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.

Interventions

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PCI-32765

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes