A Study of NPC-22 in Healthy Adult Males

The healthy adult males will be randomized into six arms, and will receive single dose of NPC-22 (five doses, placebo)

Inclusion criteria

• Subjects who have provided their own written informed consent
• Subjects aged ≥20 and <40 years at the time of informed consent
• Subjects with body weight of ≥50 kg and body mass index (BMI) (kg/m2) of ≥18.5 and <25.0
• Subjects who were identified to have no health problem on physical examination, physical assessment, laboratory tests, or other examinations at screening by the principal investigator or a sub-investigator

Exclusion criteria

• Subjects with a complication or a history of drug abuse (use of an illicit drug) or alcohol dependence
• Subjects with a history of severe disease that may recur during the study period
• Subjects with any concurrent illnesses
• Subjects who received another study drug within 180 days prior to the start of study drug administration
• Subjects who donated blood of ≥400 mL within 12 weeks, blood of ≥200 mL within 4 weeks, or blood components within 2 weeks prior to the start of the study
• Subjects who used any medicinal product (including over the counter drugs except for topical products) or similar product like a dietary supplement (including health food) within 7 days prior to the start of study drug administration
• Subjects who took any food or beverage containing grapefruit or St. John's wort within 7 days prior to the start of study drug administration
• Subjects who took any alcohol or caffeine-containing beverage within 3 days prior to the start of study drug administration
• Subjects who smoked within 90 days prior to the start of study drug administration, or do not agree to stop smoking during the study period
• Subjects who had a positive result for HBs antigen, HCV antibody, or HIV antigen/antibody, or a positive reaction to syphilis serology or urine drug test at screening
• Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator based on the 12-lead electrocardiogram at screening [e.g., Fridericia's corrected QT (QTcF) interval of ≥450 ms]
• Subjects who have a familial history of torsades de pointes or long QT syndrome
• Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator by having a deviation from the institutional reference values
• Subjects who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator due to other reasons