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

Puma Biotechnology

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: neratinib; Other: Placebo; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708903

3144A1-105

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

HKI-272

Treatment:

Drug: neratinib

2

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

3

Active Comparator group

Description:

Moxifloxacin

Treatment:

Drug: Moxifloxacin