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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 27, 2014