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Study Evaluating HKI-272 Administered to Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00366600
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : September 11, 2017
Sponsor:
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

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
U.S. FDA Resources


Intervention Details:
    Drug: neratinib
    HKI-272


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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00366600


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

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov 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
Health
Pharmacokinetics
healthy subjects