Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: HM61713

Study type: Interventional

Funder types: Industry

Identifiers

NCT01894399

HM-EMSI-102

Details and patient eligibility

About

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.

Full 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

Enrollment: 59 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 7 patient groups

Cohort 1

Experimental group

Description:

100 mg HM61713 single dose in Korean

Treatment:

Drug: HM61713

Cohort 2

Experimental group

Description:

200 mg HM61713 single dose in Korean

Treatment:

Drug: HM61713

Cohort 3

Experimental group

Description:

300 mg HM61713 single dose in Korean

Treatment:

Drug: HM61713

Cohort 4

Experimental group

Description:

200 mg HM61713 single dose in Japanese

Treatment:

Drug: HM61713

Cohort 5

Experimental group

Description:

300 mg HM61713 single dose in Japanese

Treatment:

Drug: HM61713

Cohort 6

Experimental group

Description:

200 mg HM61713 single dose in Caucasian

Treatment:

Drug: HM61713

Cohort 7

Experimental group

Description:

300 mg HM61713 single dose in Caucasian

Treatment:

Drug: HM61713