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

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

June 27, 2008
July 2, 2008
May 14, 2012
May 2008
July 2008   (Final data collection date for primary outcome measure)
QTc interval [ Time Frame: 3 days ]
Same as current
Complete list of historical versions of study NCT00708903 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart (cardiac repolarization).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Breast Cancer
  • Drug: neratinib
    HKI-272
  • Other: Placebo
    Placebo
  • Drug: Moxifloxacin
  • Experimental: 1
    HKI-272
    Intervention: Drug: neratinib
  • Placebo Comparator: 2
    Placebo
    Intervention: Other: Placebo
  • Active Comparator: 3
    Moxifloxacin
    Intervention: Drug: Moxifloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2008
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00708903
3144A1-105
No
Not Provided
Not Provided
Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
Not Provided
Study Director: Puma Biotechnology
Puma Biotechnology, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP