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