Text Size

Study Evaluating HKI-272 Administered to Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00366600
First received: August 17, 2006
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  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: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366600

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

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00366600     History of Changes
Other Study ID Numbers: 3144A1-107
Study First Received: August 17, 2006
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013