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Study Design
Primary objectives
• To assess the PK characteristics of HM61713 and metabolites in healthy male volunteers
Secondary objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 100 mg HM61713 single dose in Korean |
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| Cohort 2 | Experimental | 200 mg HM61713 single dose in Korean |
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| Cohort 3 | Experimental | 300 mg HM61713 single dose in Korean |
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| Cohort 4 | Experimental | 200 mg HM61713 single dose in Japanese |
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| Cohort 5 | Experimental | 300 mg HM61713 single dose in Japanese |
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| Cohort 6 | Experimental | 200 mg HM61713 single dose in Caucasian |
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| Cohort 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM61713 | Drug | 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Jin Jang, MD PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Seoul | South Korea |
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| ID | Term |
|---|---|
| C000617753 | olmutinib |
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| Experimental |
300 mg HM61713 single dose in Caucasian |
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