Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: HM61713

• Registration Number: NCT01894399
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief 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

Study Timeline

• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-10
• Study Start: 2013-09
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-14
• Last Update Posted: 2016-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 7	HM61713	300 mg HM61713 single dose in Caucasian
Cohort 1	HM61713	100 mg HM61713 single dose in Korean
Cohort 2	HM61713	200 mg HM61713 single dose in Korean
Cohort 3	HM61713	300 mg HM61713 single dose in Korean
Cohort 4	HM61713	200 mg HM61713 single dose in Japanese
Cohort 5	HM61713	300 mg HM61713 single dose in Japanese
Cohort 6	HM61713	200 mg HM61713 single dose in Caucasian

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration time curve from zero to infinity (AUC) of HM61713 and metabolites	0-48 hrs
Tmax of HM61713 and metabolites	0-48 hrs
Terminal half life (t1/2) of HM61713 and metabolites	0-48 hrs
The apparent plasma clearance (CL/F) of HM61713 and metabolites	0-48 hrs
Mean residence time (MRT) of HM61713 and metabolites	0-48 hrs
Maximum plasma concentration (Cmax) of HM61713 and metabolites	0-48 hrs

Secondary Outcome Measures

Name	Time	Method
Safety data, including physical examinations, laboratory evaluation, ECGs, ICGs, vital signs, and adverse events.	7 days after the investigational drug administration.

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of