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Trial record 38 of 55 for:    hki-272 OR neratinib

Study Evaluating HKI-272 Administered to Healthy 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: NCT00366600
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : September 11, 2017
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Brief Summary:
Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the same.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HKI-272 Administered Orally to Healthy Subjects.
Study Start Date : July 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Neratinib

Intervention Details:
  • Drug: neratinib

Primary Outcome Measures :
  1. Pharmacokinetics; safety and tolerability; influence of food on the same.

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

Inclusion Criteria:

  • Healthy

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): NCT00366600

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

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Responsible Party: Puma Biotechnology, Inc. Identifier: NCT00366600     History of Changes
Other Study ID Numbers: 3144A1-107
First Posted: August 21, 2006    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by Puma Biotechnology, Inc.:
Breast Cancer
healthy subjects