Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894399
• Other study ID #: HM-EMSI-102
• Status: Completed
• Phase: Phase 1
• First received: July 3, 2013
• Last updated: December 14, 2016
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: December 2016
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of HM61713 and metabolites		0-48 hrs	No
Primary	Area under the plasma concentration time curve from zero to infinity (AUC) of HM61713 and metabolites		0-48 hrs	No
Primary	Tmax of HM61713 and metabolites		0-48 hrs	No
Primary	Terminal half life (t1/2) of HM61713 and metabolites		0-48 hrs	No
Primary	The apparent plasma clearance (CL/F) of HM61713 and metabolites		0-48 hrs	No
Primary	Mean residence time (MRT) of HM61713 and metabolites		0-48 hrs	No
Secondary	Safety data, including physical examinations, laboratory evaluation, ECGs, ICGs, vital signs, and adverse events.		7 days after the investigational drug administration.	Yes