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This study aims to evaluate the effects of food or ethnicity on the pharmacokinetics and safety/tolerability of JPI-547 after a single oral administration in healthy male Korean, Caucasian, and Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Korean/Caucasian Participants: JPI-547 Fed/Fasted Crossover | Experimental | Healthy Korean and Caucasian male participants receive a single oral dose of JPI-547 in each treatment period under fed and fasted conditions in a crossover design. |
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| Chinese Participants: JPI-547 Fasted | Experimental | Healthy Chinese male participants receive a single oral dose of JPI-547 under fasting conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JPI-547 | Drug | JPI-547 is administered orally as a single dose per administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of JPI-547 | Cmax is defined as the maximum observed plasma concentration of JPI-547 after a single oral administration. | Pre-dose through 120 hours post-dose after each administration, based on 17 PK samples per administration; assessed up to Day 20 for the Korean/Caucasian fed/fasted crossover arm and up to Day 6 for the Chinese fasted arm. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of JPI-547 | AUClast is defined as the area under the plasma concentration-time curve from time zero to the last quantifiable concentration of JPI-547 after a single oral administration. | Pre-dose through 120 hours post-dose after each administration, based on 17 PK samples per administration; assessed up to Day 20 for the Korean/Caucasian fed/fasted crossover arm and up to Day 6 for the Chinese fasted arm. |
| Number of Participants With Abnormalities in Safety and Tolerability Assessments | Safety and tolerability will be assessed by monitoring adverse events, including subjective and objective symptoms, physical examinations, vital signs, 12-lead electrocardiograms, and clinical laboratory tests after a single oral administration of JPI-547. | From the first administration of JPI-547 until the Post-Study Visit; assessed up to Day 32 for the Korean/Caucasian fed/fasted crossover arm and up to Day 18 for the Chinese fasted arm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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This study consists of 2 cohorts. Cohort 1 is a randomized, open-label, crossover study to evaluate the food effect of JPI-547 in healthy Korean and Caucasian male participants. Cohort 2 is an open-label, single-dose study to explore ethnic differences in the pharmacokinetics and safety/tolerability of JPI-547 in healthy Chinese male participants under fasted conditions.
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