Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

Hanmi Pharmaceutical Company Limited59 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

HM61713DRUG

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Seoul, South Korea

Outcomes

Primary Outcomes

Maximum plasma concentration (Cmax) of HM61713 and metabolites

Time frame: 0-48 hrs

Area under the plasma concentration time curve from zero to infinity (AUC) of HM61713 and metabolites

Time frame: 0-48 hrs

Tmax of HM61713 and metabolites

Time frame: 0-48 hrs

Terminal half life (t1/2) of HM61713 and metabolites

Time frame: 0-48 hrs

The apparent plasma clearance (CL/F) of HM61713 and metabolites

Time frame: 0-48 hrs

Mean residence time (MRT) of HM61713 and metabolites

Time frame: 0-48 hrs

Secondary Outcomes

Safety data, including physical examinations, laboratory evaluation, ECGs, ICGs, vital signs, and adverse events.

Time frame: 7 days after the investigational drug administration.

Data from ClinicalTrials.gov

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