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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01767948
First received: January 9, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Hepatic Impairment
Drug: PCI-32765
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Pharmacokinetic Study of PCI-32765 in Subjects With Varying Degrees of Hepatic Impairment

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: up to Day 5 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767948

Locations
United States, California
Costa Mesa, California, United States
United States, Florida
Orlando, Florida, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01767948     History of Changes
Other Study ID Numbers: CR100944, PCI-32765CLL1006
Study First Received: January 9, 2013
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Hepatic Impairment
PCI 32765
Metabolite PCI-45227
Pharmacokinetics

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 18, 2014