Status:
COMPLETED
Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Hepatic Insufficiency
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00781430
Start Date
April 1 2009
End Date
February 1 2010
Last Update
May 14 2012
Active Locations (1)
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1
Pfizer Investigational Site
Moscow, Russia, 125206