Conditions: Healthy Adult Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 27
Healthy volunteers: yes

Brief summary:
To evaluate the effect of MCI-186 on the QT interval corrected for heart rate using Fridericia's formula (QTcF)

Detailed description:

Arms:
arm 1: Subjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment A, then Treatment C, then Treatment B (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline) arm 2: Subjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment B, then Treatment A, then Treatment C (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline) arm 3: Subjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment C, then Treatment B, then Treatment A (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline)

Interventions: intervention 1: MCI-186 intervention 2: MCI-186 intervention 3: Placebo
Intervention descriptions: intervention 1: A single dose of 60 mg MCI-186 over 60 min will be intravenously administered. intervention 2: A single dose of 300 mg MCI-186 over 60 min will be intravenously administered. intervention 3: A single dose of 0.9% w/v saline over 60 min will be intravenously administered.

Protocol document:
Prot_000.pdf: 





















































































































SAP_001.pdf: