Effect on the Electrocardiographic QT Interval Corrected for Heart Rate (QTc) in Healthy Subjects
NCT ID: NCT00979316
Last Updated: 2011-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
62 participants
INTERVENTIONAL
2009-09-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
QUADRUPLE
Study Groups
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BMS-708163 (800 mg)
BMS-708163
Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days
BMS-708163 (200 mg)
BMS-708163
Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days
Placebo
Placebo
Oral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days
Moxifloxacin
Moxifloxacin
Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days
Interventions
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BMS-708163
Oral Solution, Oral, 800 mg, Once on Day 1, approximately 14 days
BMS-708163
Oral Solution, Oral, 200 mg, Once on Day 1, approximately 14 days
Placebo
Oral Solution, Oral, 0 mg, Once on Day 1, approximately 14 days
Moxifloxacin
Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55
* Healthy subjects
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Mds Pharma Services (Us), Inc
Tempe, Arizona, United States
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CN156-020
Identifier Type: -
Identifier Source: org_study_id
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