Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

May 10, 2012 updated by: Puma Biotechnology, Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78752
    • Washington
      • Tacoma, Washington, United States, 98418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QD
Once daily
Drug: neratinib
HKI-272
Experimental: BID
Twice daily
Drug: neratinib
HKI-272

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurence of diarrhea
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puma Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Estimate)

May 14, 2012

Last Update Submitted That Met QC Criteria

May 10, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 3144A1-1116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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