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An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects - IM011-048

Actualizada: 17 May, 2018   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-50

    Rango de edad

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Dose 1
Drug: BMS-986165
Experimental: Dose 2
Drug: BMS-986165
Active Comparator: Dose 3
Drug: Moxifloxacin
Placebo Comparator: Dose 4
Other: Placebo

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator - 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: - Any medical condition that presents a potential risk and/or may compromise the objectives of the study, including a history or presence of active liver disease - 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 Other protocol defined inclusion/exclusion criteria could apply

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