A Study to Evaluate the Pharmacokinetics of PCI-32765 in Participants With Varying Degrees of Hepatic Impairment

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01767948

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

7.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: PCI-32765	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Multicenter, Pharmacokinetic Study of PCI-32765 in Subjects With Varying Degrees of Hepatic Impairment

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with mild hepatic function 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.
Experimental: Patients with moderate hepatic function 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.
Experimental: Patients with severe hepatic function 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.
Experimental: Patients with normal hepatic function 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.

Outcome Measures

Primary Outcome Measures

Maximum plasma concentration of PCI-32765 [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 [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]

Secondary Outcome Measures

Number of participants with adverse events [up to Day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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