A Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects
Phase 1
Completed
- Conditions
- Japanese Healthy Adult Male Participants
- Interventions
- Drug: Placebo
- Registration Number
- NCT02902978
- Lead Sponsor
- EA Pharma Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 56
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 to 7 E6130 Participants will receive a single dose of E6130 or placebo, administered in a dose-ascending manner under the fasted condition. Cohort 1 to 7 Placebo Participants will receive a single dose of E6130 or placebo, administered in a dose-ascending manner under the fasted condition. Cohort 8 E6130 Participants will receive a single dose of E6130 (determined in Cohort 1 to 7), administered in the specified order (fed/fasted or fasted/fed) to evaluate the food effect.
- 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 1 to 7), Days 1 to 21 (Cohort 8)
- Secondary Outcome Measures
Name Time Method 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) 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) 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) 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)