NCT01894399

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	HM61713	Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2013-07-10
• Last updated: 2016-12-15

Locations

1 site across 1 country: South Korea