Status:
COMPLETED
Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the effect of BMS-708163 on the QTc interval (QT interval corrected for heart rate).
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive.
- Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
- Healthy subjects
Exclusion
- History of cardiac arrhythmias or palpitations associated with presyncope or syncope, or history of unexplained syncope
- Sexually active fertile men not using effective birth control (double barrier) if their partners are WOCBP
- Women who are pregnant or breastfeeding
- History of allergy or intolerance to moxifloxacin or any member of the quinolone class of antimicrobial agents
- History of hypokalemia, history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
- Any clinically significant ECG abnormality
- History of seizure disorders
- History of drowning survival
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00979316
Start Date
September 1 2009
End Date
February 1 2010
Last Update
January 7 2011
Active Locations (1)
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1
Mds Pharma Services (Us), Inc
Tempe, Arizona, United States, 85283