Healthy Volunteers Clinical Trial
Official title:
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
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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