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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498745
First Posted: July 10, 2007
Last Update Posted: May 14, 2012
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.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
  Purpose
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 Intervention Phase
Healthy Drug: neratinib Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 36
Study Start Date: July 2007
Study Completion Date: September 2007
Intervention Details:
    Drug: neratinib
    HKI-272
  Eligibility

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
Criteria

Criteria:

  • Healthy male and female subjects aged 18 to 50 years.
  • Women of nonchildbearing potential (WONCBP)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00498745


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

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00498745     History of Changes
Other Study ID Numbers: 3144A1-1109
First Submitted: July 9, 2007
First Posted: July 10, 2007
Last Update Posted: May 14, 2012
Last Verified: May 2012