Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Decision of Sponsor
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of E6130 in Japanese healthy adult male participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1 | Experimental | Japanese participants will receive a single oral dose of E6130 on Day 1 and Day 7 administered in the specified order (fasted/fed or fed/fasted) to evaluate the food effect. |
|
| Cohort B1 | Experimental | Caucasian participants will receive a single oral dose of either E6130 or placebo on Day 1. |
|
| Cohorts A2-A4 | Experimental | Japanese participants will receive multiple oral doses of E6130 or placebo on Days 1 to 5, administered in a randomized, dose-ascending manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E6130 | Drug | Oral dose |
| |
| 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 A1); Days 1 to 12 (Cohorts A2 to A4); Days 1 to 8 (Cohort B1) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) of E6130 | Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1) | |
| Maximum observed serum concentration at steady state (Css, max) of E6130 | Days 1 to 7 (Cohorts A2 to A4) |
Not provided
Inclusion Criteria:
Participants must meet all of the following criteria to be included in this study.
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
E6130-matched placebo |
|
| Time to Cmax (tmax) of E6130 | Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1) |
| Time to Cmax at steady state (tss, max) of E6130 | Days 1 to 7 (Cohorts A2 to A4) |
| Area under the serum concentration-time curve from zero time to the time of last quantifiable concentration (AUC[0-t]) of E6130 | Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1) |
| Area under the serum concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) of E6130 | Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1) |
| Area under the serum concentration-time curve from zero time to 24 hours (AUC[0-24h]) of E6130 | Days 1 to 7 (Cohorts A2 to A4) |
| Terminal elimination phase half-life (t1/2) of E6130 | Days 1 to 7 (Cohorts A2 to A4) |