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

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Janssen (J&J Innovative Medicine)

Status and phase

Completed
Phase 1

Conditions

Hepatic Impairment

Treatments

Drug: PCI-32765

Study type

Interventional

Funder types

Industry

Identifiers

NCT01767948
PCI-32765CLL1006 (Other Identifier)
CR100944

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 4 patient groups

Patients with mild hepatic function
Experimental group
Description:
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
Treatment:
Drug: PCI-32765
Patients with moderate hepatic function
Experimental group
Description:
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
Treatment:
Drug: PCI-32765
Patients with severe hepatic function
Experimental group
Description:
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
Treatment:
Drug: PCI-32765
Patients with normal hepatic function
Experimental group
Description:
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
Treatment:
Drug: PCI-32765

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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