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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
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 A1); Days 1 to 12 (Cohorts A2 to A4); Days 1 to 8 (Cohort B1)
Maximum observed serum concentration (Cmax) of E6130
Time frame: 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
Time frame: Days 1 to 7 (Cohorts A2 to A4)
Time to Cmax (tmax) of E6130
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Days 1 to 7 (Cohorts A2 to A4)
Terminal elimination phase half-life (t1/2) of E6130
Time frame: Days 1 to 7 (Cohorts A2 to A4)
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