A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Adult Male Participants
- Registration Number
- NCT03390647
- Lead Sponsor
- EA Pharma Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Participants must meet all of the following criteria to be included in this study.
- Japanese or Caucasian healthy adult males aged ≥20 and <45 years at the time of informed consent who are non-smokers or able to stop smoking from at least 4 weeks before study drug administration until the post-treatment examination
- Has voluntarily consented, in writing, to participate in this study
- Has been thoroughly briefed on the conditions for participation in the study, and are willing and able to comply with the conditions
Exclusion Criteria
Participants who meet any of the following criteria will be excluded from this study.
- History of surgical treatment may affect the pharmacokinetics of the study drug at screening
- Suspected to have clinically abnormal symptoms or impairment of organ function requiring treatment on the basis of history and complications at screening, and physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline
- History of drug allergy at screening
- Judged by the investigator or sub investigator to be inappropriate for participation in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort B1 E6130 Caucasian participants will receive a single oral dose of either E6130 or placebo on Day 1. Cohort A1 E6130 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 Placebo Caucasian participants will receive a single oral dose of either E6130 or placebo on Day 1. Cohorts A2-A4 Placebo Japanese participants will receive multiple oral doses of E6130 or placebo on Days 1 to 5, administered in a randomized, dose-ascending manner. Cohorts A2-A4 E6130 Japanese participants will receive multiple oral doses of E6130 or placebo on Days 1 to 5, administered in a randomized, dose-ascending manner.
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method 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) 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) 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) Terminal elimination phase half-life (t1/2) of E6130 Days 1 to 7 (Cohorts A2 to A4)