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

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ClinicalTrials.gov Identifier: NCT00708903
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : May 14, 2012
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: neratinib Other: Placebo Drug: Moxifloxacin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Single Dose, Crossover, Placebo- and Moxifloxacin-Controlled Study of the Effects of HKI-272 on Cardiac Repolarization in Healthy Adult Subjects
Study Start Date : May 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
HKI-272
Drug: neratinib
HKI-272
Placebo Comparator: 2
Placebo
Other: Placebo
Placebo
Active Comparator: 3
Moxifloxacin
Drug: Moxifloxacin



Primary Outcome Measures :
  1. QTc interval [ Time Frame: 3 days ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708903


Locations
United States, Washington
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Puma Biotechnology

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00708903     History of Changes
Other Study ID Numbers: 3144A1-105
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

Keywords provided by Puma Biotechnology, Inc.:
Thorough QTc study

Additional relevant MeSH terms:
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors