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

Phase 1CompletedNCT00708903

Puma Biotechnology, Inc.60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Breast Cancer

Interventions

neratinibDRUG

HKI-272

PlaceboOTHER

Placebo

MoxifloxacinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Tacoma, Washington, United States

Outcomes

Primary Outcomes

QTc interval

Time frame: 3 days

Data from ClinicalTrials.gov

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