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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00498745
Recruitment Status : Completed
First Posted : July 10, 2007
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: neratinib Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : July 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Neratinib
U.S. FDA Resources

Intervention Details:
    Drug: neratinib

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • Healthy male and female subjects aged 18 to 50 years.
  • Women of nonchildbearing potential (WONCBP)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00498745

United States, Texas
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Puma Biotechnology, Inc.
Study Director: Puma Biotechnology

Responsible Party: Puma Biotechnology, Inc. Identifier: NCT00498745     History of Changes
Other Study ID Numbers: 3144A1-1109
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012