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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

June 27, 2008
May 10, 2012
May 2008
July 2008   (final data collection date for primary outcome measure)
QTc interval [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00708903
3144A1-105
No
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