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Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects

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: NCT00550212
Recruitment Status : Completed
First Posted : October 29, 2007
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Brief Summary:
The purpose of this study is to evaluate the mass balance and metabolic distribution of C14-labeled HKI-272 in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: neratinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-Labeled HKI-272 in Healthy Male Subjects
Study Start Date : March 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Neratinib

Arm Intervention/treatment
Experimental: 1
240 mg
Drug: neratinib
HKI-272, Single-dose capsule and solution

Primary Outcome Measures :
  1. Mass balance, metabolic distribution, PK [ Time Frame: 10 days ]

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:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male subjects, aged 18 to 50 years.

Exclusion Criteria:

  • Female subjects

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): NCT00550212

Sponsors and Collaborators
Puma Biotechnology, Inc.
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Study Director: Puma Biotechnology

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Responsible Party: Puma Biotechnology, Inc. Identifier: NCT00550212     History of Changes
Other Study ID Numbers: 3144A1-1108
First Posted: October 29, 2007    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

Keywords provided by Puma Biotechnology, Inc.:
healthy subjects