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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
History of Changes
  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: 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

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Criteria:

  • Healthy male and female subjects aged 18 to 50 years.
  • Women of nonchildbearing potential (WONCBP)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498745

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

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00498745     History of Changes
Other Study ID Numbers: 3144A1-1109
Study First Received: July 9, 2007
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 16, 2013