A Study to Evaluate the Pharmacokinetics of PCI-32765 in Participants With Varying Degrees of Hepatic Impairment
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of PCI 32765 in participants with mild, moderate, or severe hepatic impairment.
Key facts
- Study ID
- NCT01767948
- Run by
- Janssen Research & Development, LLC
- People needed
- 30
- Starts
- 2012-12-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2014-10-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured within 48 hours prior to PCI-32765 administration
- Must be hepatically impaired as defined by the Child-Pugh classification of severity of liver disease
- Control group must have good health with normal liver function
- Participants with controlled hypertension and those with problems directly associated with the primary diagnosis of hepatic impairment
- Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed
- Agrees to protocol-defined use of effective contraception
You may not qualify if…
- Clinically significant renal laboratory findings including serum creatinine more than 1.5 x the upper limit of normal (ULN) and/or calculated creatinine clearance of less than 60 ml per minute per 1.73 square meter
- Clinically significant abnormal laboratory tests, physical examination, vital signs or electrocardiogram at screening or at admission to the study center
- Antiviral therapy for active hepatitis infection at time of screening
- Use of any anti-coagulation therapy including vitamin K antagonists, low molecular weight heparin, or other anticoagulants
Where it is running
- Study site — Costa Mesa, California, United States
- Study site — Orlando, Florida, United States
- Study site — Knoxville, Tennessee, United States
- Study site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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