A Phase 1 interventional study of PCI-32765 in Hepatic Impairment, sponsored by Janssen Research & Development, LLC. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-10-07.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
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.
This is an open-label (all people know the identity of the intervention), single-dose, multi-center (study conducted at multiple sites), non-randomized study to access the pharmacokinetics of PCI-32765 in participants who either have mild, moderate, or severe hepatic impairment or qualify for the control group (normal liver function). The study mainly consists of 3 phases: screening phase (within 21 days prior to the first dose of study medication), treatment phase, and a follow up phase (10 to 12 days after the last dose of study medication). In the treatment phase, participants will receive single oral dose of PCI-32765 on Day 1. Liver impairment will be classified according to the Child-Pugh Classification of Severity of Liver Disease, as: normal, mild, moderate, and severe. Total 30 participants (24 with hepatic impairment [6 mild, 9 moderate and 9 severe] at baseline and 6 in the control group according to Child-Pugh criteria) will be enrolled. Participants in the control group will be enrolled after the participants with mild or moderate hepatic impairment have completed the study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. The total duration of study for each participant will be approximately for 29 to 33 days.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
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Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
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Exclusion Criteria:
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
Drug: PCI-32765
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
Drug: PCI-32765
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
Drug: PCI-32765
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
Drug: PCI-32765
PCI-32765 140 mg will be administered as a single dose, orally, on Day 1.
Maximum plasma concentration of PCI-32765
Time frame: Predose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours, and 96 hours
Area under the plasma concentration of PCI-32765
Time frame: Predose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours, and 96 hours
Number of participants with adverse events
Time frame: up to Day 5
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC