Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

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: NCT00757809
Recruitment Status : Completed
First Posted : September 23, 2008
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Neratinib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: QD
Once daily
Drug: neratinib
Experimental: BID
Twice daily
Drug: neratinib

Primary Outcome Measures :
  1. Occurence of diarrhea [ Time Frame: 14 days ]

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 male and female (non-child bearing potential) subjects
  • Ages 18-50.

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): NCT00757809

United States, Texas
Austin, Texas, United States, 78752
United States, Washington
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Puma Biotechnology, Inc.
Study Director: Puma Biotechnology

Responsible Party: Puma Biotechnology, Inc. Identifier: NCT00757809     History of Changes
Other Study ID Numbers: 3144A1-1116
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012