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

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PCI-32765

About this trial

This is an interventional treatment trial for Hepatic Impairment focused on measuring Hepatic Impairment, PCI 32765, Metabolite PCI-45227, Pharmacokinetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Patients with mild hepatic function

Patients with moderate hepatic function

Patients with severe hepatic function

Patients with normal hepatic function

Arm Description

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

Outcomes

Primary Outcome Measures

Maximum plasma concentration of PCI-32765

Area under the plasma concentration of PCI-32765

Secondary Outcome Measures

Number of participants with adverse events

Full Information

NCT ID

NCT01767948

First Posted

January 9, 2013

Last Updated

October 6, 2014

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01767948

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

Keywords

Hepatic Impairment, PCI 32765, Metabolite PCI-45227, Pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with mild hepatic function

Arm Type

Experimental

Arm Description

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

Arm Title

Patients with moderate hepatic function

Arm Type

Experimental

Arm Description

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

Arm Title

Patients with severe hepatic function

Arm Type

Experimental

Arm Description

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

Arm Title

Patients with normal hepatic function

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PCI-32765

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

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

Secondary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

up to Day 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

City

Costa Mesa

State/Province

California

Country

United States

City

Orlando

State/Province

Florida

Country

United States

City

Knoxville

State/Province

Tennessee

Country

United States

City

San Antonio

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27267254

Citation

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.

Results Reference

derived

Links:

URL

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

Description

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

Learn more about this trial

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

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