NCT01767948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

11 months

First QC Date

January 9, 2013

Last Update Submit

October 6, 2014

Conditions

Hepatic Impairment

Keywords

Hepatic ImpairmentPCI 32765Metabolite PCI-45227Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Number of participants with adverse events

    up to Day 5

Study Arms (4)

Patients with mild hepatic function

EXPERIMENTAL

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

Drug: PCI-32765

Patients with moderate hepatic function

EXPERIMENTAL

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

Drug: PCI-32765

Patients with severe hepatic function

EXPERIMENTAL

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

Drug: PCI-32765

Patients with normal hepatic function

EXPERIMENTAL

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

Drug: PCI-32765

Interventions

PCI-32765DRUG

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

Patients with mild hepatic functionPatients with moderate hepatic functionPatients with normal hepatic functionPatients with severe hepatic function

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Costa Mesa, California, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Related Publications (1)

  • 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.

    PMID: 27267254DERIVED

Related Links

MeSH Terms

Interventions

ibrutinib

Study Officials

  • Janssen Research & Development, LLC Clinical trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 15, 2013

Study Start

December 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

October 7, 2014

Record last verified: 2014-10

Locations

US(4)