Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

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: NCT00814060
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Subjects Drug: neratinib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Neratinib

Arm Intervention/treatment
Experimental: 1
40-mg tablet
Drug: neratinib

Experimental: 2
240-mg tablet
Drug: neratinib

Experimental: 3
80-mg capsule
Drug: neratinib

Primary Outcome Measures :
  1. Blood will be collected to determine the pharmacokinetics of the various formulations of HKI-272 [ Time Frame: 6 weeks ]

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, ages 18-50.

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): NCT00814060

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

Responsible Party: Puma Biotechnology, Inc. Identifier: NCT00814060     History of Changes
Other Study ID Numbers: 3144A1-1117
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012