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Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00814060
First received: December 17, 2008
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.


Condition Intervention Phase
Healthy Subjects
 Drug: neratinib
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose Bioavailability Study of 2 New Tablet Formulations of Neratinib Compared With a Reference Capsule in Healthy Adult Subjects

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

Primary Outcome Measures:
  • Blood will be collected to determine the pharmacokinetics of the various formulations of HKI-272 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
40-mg tablet
 Drug: neratinib
HKI-272
Experimental: 2
240-mg tablet
 Drug: neratinib
HKI-272
Experimental: 3
80-mg capsule
 Drug: neratinib
HKI-272

  Eligibility

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

Healthy male and female subjects, ages 18-50.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814060

Locations
United States, Washington
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Puma Biotechnology
  More Information

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00814060     History of Changes
Other Study ID Numbers: 3144A1-1117
Study First Received: December 17, 2008
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013