An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects
NCT ID: NCT03541564
Last Updated: 2020-01-27
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
84 participants
INTERVENTIONAL
2018-05-30
2018-09-04
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
TREATMENT
QUADRUPLE
Study Groups
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BMS-986165 Dose 1 oral administration
BMS-986165 therapeutic single dose
BMS-986165
Specified dose on specified days
BMS-986165 Dose 2 oral administration
BMS-986165 supratherapeutic single dose
BMS-986165
Specified dose on specified days
Moxifloxacin Dose 3 oral administration
Moxifloxacin positive control single dose
Moxifloxacin
Specified dose on specified days
Placebo Dose 4 oral administration
Placebo single dose
Placebo
Specified dose on specified days
Interventions
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BMS-986165
Specified dose on specified days
Moxifloxacin
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 mL/min/1.732 m2
Exclusion Criteria
* A personal history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
* History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
18 Years
50 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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PRA Health Sciences
Lenexa, Kansas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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IM011-048
Identifier Type: -
Identifier Source: org_study_id
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