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
  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:


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
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, see Learn About Clinical Studies.

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 September 18, 2014