Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

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

Completed

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Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Austin, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Neratinib

Drug

HKI-272

Primary outcomes

Occurence of diarrhea

Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Puma Biotechnology, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Sep 23, 2008
Registry last updated: May 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed