Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)

The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart (cardiac repolarization).

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Men or women of nonchildbearing potential,
18-50 years old.
Healthy as determined by the investigator, including physical examination, laboratory test results, and medical history.

Treatment and study plan

Neratinib

Drug

HKI-272

Placebo

Other

Placebo

moxifloxacin

Drug

Primary outcomes

QTc interval

Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Puma Biotechnology, Inc.

Industry

Registry information

Official study title

A Single Dose, Crossover, Placebo- and Moxifloxacin-Controlled Study of the Effects of HKI-272 on Cardiac Repolarization in Healthy Adult Subjects

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Jul 2, 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