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
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart (cardiac repolarization).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 breast-cancer
Started May 2008
Shorter than P25 for phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedMay 14, 2012
May 1, 2012
2 months
June 27, 2008
May 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
QTc interval
3 days
Study Arms (3)
1
EXPERIMENTALHKI-272
2
PLACEBO COMPARATORPlacebo
3
ACTIVE COMPARATORMoxifloxacin
Interventions
Eligibility Criteria
You may qualify if:
- Men or women of nonchildbearing potential,
- years old.
- Healthy as determined by the investigator, including physical examination, laboratory test results, and medical history.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Tacoma, Washington, 98418, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Puma
Biotechnology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2008
First Posted
July 2, 2008
Study Start
May 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
May 14, 2012
Record last verified: 2012-05