A Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1 Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects

Conditions
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Japanese Healthy Adult Male Participants

Intervention / Treatment
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* Drug: E6130
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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. Has voluntarily consented, in writing, to participate in this study. Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions. Exclusion Criteria History of surgical treatment that 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, ECG 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 to 7<br>Participants will receive a single dose of E6130 or placebo, administered in a dose-ascending manner under the fasted condition. | Drug: E6130<br> <br> Drug: Placebo<br>* E6130 matched placebo<br>|
| Experimental: Cohort 8<br>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. | Drug: E6130<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E6130, Japanese healthy adult male participants, Phase 1, Pharmacokinetics