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Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00757809
First received: September 19, 2008
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

Study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days.


Condition Intervention Phase
Healthy Subjects
 Drug: neratinib
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Blinded, Randomized, Multiple-Dose, Parallel Group Study to Characterize the Occurrence of Mild to Moderate Diarrhea After Administration of Neratinib Either 240-mg Once Daily or 120-mg Twice Daily for 14 Days to Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

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

Primary Outcome Measures:
  • Occurence of diarrhea [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: October 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QD
Once daily
 Drug: neratinib
HKI-272
Experimental: BID
Twice daily
 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 male and female (non-child bearing potential) subjects
  • Ages 18-50.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757809

Locations
United States, Texas
Austin, Texas, United States, 78752
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: NCT00757809     History of Changes
Other Study ID Numbers: 3144A1-1116
Study First Received: September 19, 2008
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013