Thorough QT/QTc study for Garenoxacin

INTERVENTION: Product Name: Garenoxacin Product Code: SCH 575737 Pharmaceutical Form: Powder for oral suspension Pharmaceutical form of the placebo: Powder and solvent for oral suspension Route of administration of the placebo: Oral use Product Name: Garenoxacin Product Code: SCH 575737 Pharmaceutical Form: Powder for oral suspension Pharmaceutical form of the placebo: Powder and solvent for oral suspension Route of administration of the placebo: Oral use Trade Name: Avelox 400 mg Pharmaceutical Form: Tablet CONDITION: Indication: bacterial infections ; MedDRA version: 8.1 Level: HLT Classification code 10004047 Term: Bacterial infections NEC PRIMARY OUTCOME: Main Objective: to evaluate QT/QTc prolongation and proarrhythmic potential for garenoxacin using a placebo control and moxifloxacin as the positive control in adult healthy volunteers Primary end point(s): Part 1:; to evaluate the safety, tolerability and pharmacokinetics of garenoxacin at supra‐therapeutic doses in normal healthy volunteers as determined by Cmax, AUC (0‐24 hours), reported AE, vital signs, safety laboratory tests, ECG and physical examinations; ; Part 2:; the effect of supra‐therapeutic dose of garenoxacin following 5 days of treatment on QT intervals, corrected with Fredericia's method (QTcf), as measured by the largest upper bound of 95% one‐sided confidence intervals for the eight mean changes in QTcf from time‐matched baseline ECG recordings, compared to placebo Secondary Objective: to evaluate safety, tolerability and pharmacokinetics of garenoxacin at supratherapeutic doses in adult healthy volunteers INCLUSION CRITERIA: Age between 18 and 55 years, inclusive BMI between 19 to 32 kg/m2, inclusive Free of any significant disease that would interfere with the study evaluations ECG and vital signs withing normal ranges Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range