Hepatic Insufficiency
Conditions
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.
Interventions
Neratinib 40-mg oral tablets. SINGLE DOSE of 120-mg (3 x 40-mg tablets)
Sponsors
Puma Biotechnology, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. | 4 weeks |
Countries
Russia
Outcome results
None listed