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

Hepatic Insufficiency Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781430
• Other study ID #: 3144A1-1111
• Secondary ID: B1891009
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2008
• Last updated: May 10, 2012
• Start date: April 2009
• Est. completion date: February 2010

Study information

• Verified date: May 2012
• Source: Puma Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics CommitteeRussia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatic Insufficiency

Intervention

Drug:
• Neratinib (HKI-272)
Neratinib 40-mg oral tablets. SINGLE DOSE of 120-mg (3 x 40-mg tablets)

Locations

Country	Name	City	State
Russian Federation	Pfizer Investigational Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Puma Biotechnology, Inc.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.		4 weeks	Yes