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

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: neratinib; Other: Placebo; Drug: Moxifloxacin

• Registration Number: NCT00708903
• Lead Sponsor: Puma Biotechnology, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-27
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted QC: 2008-07-01
• Study First Posted: 2008-07-02
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	neratinib	HKI-272
2	Placebo	Placebo
3	Moxifloxacin	Moxifloxacin

Primary Outcome Measures

Name	Time	Method
QTc interval	3 days