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The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of a single dose of E6130 in Japanese healthy adult male participants.
This study consists of 8 cohorts, Cohorts 1 to 8. Cohorts 1 to 7 are designed as a single-center, single dose, placebo-controlled, randomized, ascending dose, double-blind study. Cohort 8 is designed as a single-center, single dose, randomized, open-label, two-group, two-period crossover study. Cohort 8 will be initiated after Cohorts 1 to 7 are completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 to 7 | Experimental | Participants will receive a single dose of E6130 or placebo, administered in a dose-ascending manner under the fasted condition. |
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| Cohort 8 | Experimental | Participants will receive a single dose of E6130 (determined in Cohort 1 to 7), administered in the specified order (fed/fasted or fasted/fed) to evaluate the food effect. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E6130 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability | Days 1 to 14 (Cohort 1 to 7), Days 1 to 21 (Cohort 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) of E6130 | Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8) | |
| Time to Cmax (Tmax) of E6130 | Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8) |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumida City | Tokyo | Japan |
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E6130 matched placebo |
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| Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) of E6130 | Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8) |
| Area under the serum concentration-time curve from time zero to infinity (AUC(0-inf)) of E6130 | Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8) |
| Apparent terminal phase half-life (t1/2) of E6130 | Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8) |