Trials / Completed
CompletedNCT00781430
Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Puma Biotechnology, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Neratinib (HKI-272) | Neratinib 40-mg oral tablets. SINGLE DOSE of 120-mg (3 x 40-mg tablets) |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2010-02-01
- Completion
- 2010-02-01
- First posted
- 2008-10-29
- Last updated
- 2012-05-14
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT00781430. Inclusion in this directory is not an endorsement.