Japanese Healthy Adult Male Participants
Conditions
Keywords
E6130, Japanese healthy adult male participants, Phase 1, Pharmacokinetics
Brief summary
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.
Detailed description
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.
Interventions
DRUGE6130
DRUGPlacebo
E6130 matched placebo
Sponsors
EA Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
1. Japanese 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 is willing and able to comply with the conditions.
Exclusion criteria
1. History of surgical treatment that 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, ECG 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 1 to 7), Days 1 to 21 (Cohort 8) |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed serum concentration (Cmax) of E6130 | Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8) |
| Time to Cmax (Tmax) of E6130 | 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 | 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 | 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 | Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8) |
Countries
Japan
Outcome results
None listed