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Study Evaluating HKI-272 Administered to Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00366600
First Posted: August 21, 2006
Last Update Posted: September 11, 2017
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.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
  Purpose
Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the same.

Condition Intervention Phase
Healthy Drug: neratinib Phase 1

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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

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

Enrollment: 56
Study Start Date: July 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: neratinib
    HKI-272
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  Contacts and Locations
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
  More Information

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00366600     History of Changes
Other Study ID Numbers: 3144A1-107
First Submitted: August 17, 2006
First Posted: August 21, 2006
Last Update Posted: September 11, 2017
Last Verified: September 2017

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