Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00498745
First received: July 9, 2007
Last updated: May 10, 2012
Last verified: May 2012

July 9, 2007
May 10, 2012
July 2007
Not Provided
The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for HKI-272 to support formulation development.
Same as current
Complete list of historical versions of study NCT00498745 on ClinicalTrials.gov Archive Site
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Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects
A Single Dose Bioavailability Study of 2 New Formulations of HKI-272 (240 mg) Compared With a Reference Capsule and an Oral Solution in Healthy Adult Subjects

To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
Drug: neratinib
HKI-272
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
September 2007
Not Provided

Criteria:

  • Healthy male and female subjects aged 18 to 50 years.
  • Women of nonchildbearing potential (WONCBP)
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00498745
3144A1-1109
Not Provided
Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
Not Provided
Study Director: Puma Biotechnology
Puma Biotechnology, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP