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

NCT ID: NCT00708903

Last Updated: 2012-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-07-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

HKI-272

Group Type EXPERIMENTAL

neratinib

Intervention Type DRUG

HKI-272

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

3

Moxifloxacin

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

Interventions

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neratinib

HKI-272

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Moxifloxacin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Puma Biotechnology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Puma

Role: STUDY_DIRECTOR

Biotechnology

Locations

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Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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3144A1-105

Identifier Type: -

Identifier Source: org_study_id

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