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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00708903

Enrollment

Registered

2008-07-02

Start date

2008-05-31

Completion date

2008-07-31

Last updated

2012-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Thorough QTc study

Brief summary

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

Interventions

DRUGneratinib

HKI-272

OTHERPlacebo

Placebo

DRUGMoxifloxacin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
QTc interval	3 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026