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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-26

Study Completion Date

2017-08-17

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.

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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.

Conditions

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Japanese Healthy Adult Male Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1 to 7

Participants will receive a single dose of E6130 or placebo, administered in a dose-ascending manner under the fasted condition.

Group Type EXPERIMENTAL

E6130

Intervention Type DRUG

Placebo

Intervention Type DRUG

E6130 matched placebo

Cohort 8

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.

Group Type EXPERIMENTAL

E6130

Intervention Type DRUG

Interventions

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E6130

Intervention Type DRUG

Placebo

E6130 matched placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

44 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes