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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:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00708903
First received: June 27, 2008
Last updated: May 10, 2012
Last verified: May 2012
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708903

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

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00708903     History of Changes
Other Study ID Numbers: 3144A1-105
Study First Received: June 27, 2008
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014