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Completed

NCT Number: NCT00781430

Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease

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.

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Key information

Conditions

Hepatic Insufficiency Digestive System Diseases Liver Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Moscow, 125206, Russia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Neratinib (HKI-272)

Drug

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

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.

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Puma Biotechnology, Inc.

Industry

Registry information

Official study title

An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Neratinib In Subjects With Chronic Hepatic Impairment And In Matched Healthy Adults

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 29, 2008
Registry last updated
May 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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