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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00708903
First Posted: July 2, 2008
Last Update Posted: May 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
  Purpose
The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart (cardiac repolarization).

Condition Intervention Phase
Breast Cancer Drug: neratinib Other: Placebo Drug: Moxifloxacin Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Puma Biotechnology, Inc.:

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

Enrollment: 60
Study Start Date: May 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
HKI-272
Drug: neratinib
HKI-272
Placebo Comparator: 2
Placebo
Other: Placebo
Placebo
Active Comparator: 3
Moxifloxacin
Drug: Moxifloxacin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00708903     History of Changes
Other Study ID Numbers: 3144A1-105
First Submitted: June 27, 2008
First Posted: July 2, 2008
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