Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

Study Overview
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Brief Summary
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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
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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

Official Title
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Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic Characteristics of HM61713 Tablet in Healthy Korean, Japanese and Caucasian

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: HM61713


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>100 mg HM61713 single dose in Korean | Drug: HM61713<br>* 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<br>* Other names: Olmutinib;|
| Experimental: Cohort 2<br>200 mg HM61713 single dose in Korean | Drug: HM61713<br>* 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<br>* Other names: Olmutinib;|
| Experimental: Cohort 3<br>300 mg HM61713 single dose in Korean | Drug: HM61713<br>* 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<br>* Other names: Olmutinib;|
| Experimental: Cohort 4<br>200 mg HM61713 single dose in Japanese | Drug: HM61713<br>* 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<br>* Other names: Olmutinib;|
| Experimental: Cohort 5<br>300 mg HM61713 single dose in Japanese | Drug: HM61713<br>* 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<br>* Other names: Olmutinib;|
| Experimental: Cohort 6<br>200 mg HM61713 single dose in Caucasian | Drug: HM61713<br>* 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<br>* Other names: Olmutinib;|
| Experimental: Cohort 7<br>300 mg HM61713 single dose in Caucasian | Drug: HM61713<br>* 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<br>* Other names: Olmutinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of HM61713 and metabolites |  | 0-48 hrs | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety data, including physical examinations, laboratory evaluation, ECGs, ICGs, vital signs, and adverse events. |  | 7 days after the investigational drug administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, HM61713, pharmacokinetics, healthy, olmutinib