Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic Characteristics of HM61713 Tablet in Healthy Korean, Japanese and Caucasian

Study Design

• Open, escalating single-dose design.
• 7 ascending dose cohorts
• In each cohorts, subjects will receive a single dose of HM61713.
• Main objective of this study is to evaluate the pharmacokinetics of HM61713 tablet.

Primary objectives

• To assess the PK characteristics of HM61713 and metabolites in healthy male volunteers

Secondary objectives

• To assess the safety and tolerability of HM61713 tablet in healthy male subjects.
• To assess the food effect on PK characteristics of HM61713 tablet in healthy male subjects.
• To assess the ethnic differences of PK characteristics of HM61713 (Korean, Japanese, Caucasian)
• To investigate genotype of drug metabolism.transport that affect PK characteristics of HM61713
• To investigate the change of endogenous metabolic markers after administration of HM61713

Inclusion Criteria:

• Healthy male volunteers, age between 20 and 45
• Informed of the investigational nature of this study and voluntarily agree to participate in this study
• BMI of >18.5kg/m2 and <28kg/m2 subject

Exclusion Criteria:

• Use of any prescription medication within 2 weeks prior to Day 1
• Use of any medication within 1 weeks prior to Day 1
• Has a severe medical history of hypersensitivity to drug
• Participation in another clinical study within 8 weeks days prior to start of study drug administration