Healthy Participants
Conditions
Keywords
E6130, Healthy adult male participants, Phase 1, Pharmacokinetics
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.
Interventions
DRUGE6130
Oral dose
DRUGPlacebo
E6130-matched placebo
Sponsors
EA Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must meet all of the following criteria to be included in this study. 1. 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 2. Has voluntarily consented, in writing, to participate in this study 3. 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. 1. History of surgical treatment may affect the pharmacokinetics of the study drug at screening 2. 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 3. History of drug allergy at screening 4. Judged by the investigator or sub investigator to be inappropriate for participation in this study
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Maximum observed serum concentration (Cmax) 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) |
| 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) |
Outcome results
None listed