NCT00781430

Brief Summary

The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

10 months

First QC Date

October 28, 2008

Last Update Submit

May 10, 2012

Conditions

Hepatic Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of neratinib in healthy volunteers compared to hepatically impaired patients through analysis of blod samples collected after neratinib administration in these 2 populations.

    4 weeks

Secondary Outcomes (1)

  • Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.

    4 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: Neratinib (HKI-272)

Interventions

Neratinib (HKI-272)DRUG

Neratinib 40-mg oral tablets. SINGLE DOSE of 120-mg (3 x 40-mg tablets)

1

Eligibility Criteria

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

You may qualify if:

  • Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening.
  • WONCBP may be included if they are either surgically sterile (hysterectomy or oophorectomy) or postmenopausal for =1 year (with follicle-stimulating hormone \[FSH\] level =38 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. 2-Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay. 3-Have a high probability for compliance with and completion of the study

You may not qualify if:

  • Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related death. 2-Presence or history of any disorder that may prevent the successful completion of the study. 3-History of drug abuse within 1 year before study day 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Moscow, 125206, Russia

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

neratinib

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Puma

    Biotechnology

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 29, 2008

Study Start

April 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations

RU(1)