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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT01763021

Run by

Janssen Research & Development, LLC

People needed

18

Starts

2012-12-01

Expected to finish

2013-01-01

Last updated by the study team

2013-04-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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