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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
56
Unnamed facility
Sumida City, Tokyo, Japan
Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability
Time frame: Days 1 to 14 (Cohort 1 to 7), Days 1 to 21 (Cohort 8)
Maximum observed serum concentration (Cmax) of E6130
Time frame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
Time to Cmax (Tmax) of E6130
Time frame: 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 time t (AUC(0-t)) of E6130
Time frame: 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
Time frame: 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
Time frame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
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