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

NCT ID: NCT01767948

Last Updated: 2014-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-11-30

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.

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.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with mild hepatic function

Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.

Group Type: EXPERIMENTAL

PCI-32765

Intervention Type: DRUG

PCI-32765 140 mg will be administered as a single dose, orally, on Day 1.

Patients with moderate hepatic function

Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.

Group Type: EXPERIMENTAL

PCI-32765

Intervention Type: DRUG

PCI-32765 140 mg will be administered as a single dose, orally, on Day 1.

Patients with severe hepatic function

Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.

Group Type: EXPERIMENTAL

PCI-32765

Intervention Type: DRUG

PCI-32765 140 mg will be administered as a single dose, orally, on Day 1.

Patients with normal hepatic function

Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.

Group Type: EXPERIMENTAL

PCI-32765

Intervention Type: DRUG

PCI-32765 140 mg will be administered as a single dose, orally, on Day 1.

Interventions

PCI-32765

PCI-32765 140 mg will be administered as a single dose, orally, on Day 1.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Costa Mesa, California, United States

Orlando, Florida, United States

Knoxville, Tennessee, United States

San Antonio, Texas, United States

Countries

United States

References

de Jong J, Skee D, Hellemans P, Jiao J, de Vries R, Swerts D, Lawitz E, Marbury T, Smith W, Sukbuntherng J, Mannaert E. Single-dose pharmacokinetics of ibrutinib in subjects with varying degrees of hepatic impairment<sup/> Leuk Lymphoma. 2017 Jan;58(1):185-194. doi: 10.1080/10428194.2016.1189548. Epub 2016 Jun 7.

Reference Type: DERIVED

PMID: 27267254 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3612&filename=CR100944_CSR.pdf

An Open-Label, Multicenter, Pharmacokinetic Study of PCI-32765 in Subjects with Varying Degrees of Hepatic Impairment(18343).

Other Identifiers

PCI-32765CLL1006

Identifier Type: OTHER

Identifier Source: secondary_id

CR100944

Identifier Type: -

Identifier Source: org_study_id