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NCT Number: NCT02902978

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

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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Key information

Conditions

Japanese Healthy Adult Male Participants

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sumida City, Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E6130

Drug

Placebo

Drug

E6130 matched placebo

Primary outcomes

  1. Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability

    Time frame: Days 1 to 14 (Cohort 1 to 7), Days 1 to 21 (Cohort 8)

Secondary outcomes

  1. Maximum observed serum concentration (Cmax) of E6130

    Time frame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)

  2. Time to Cmax (Tmax) of E6130

    Time frame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)

  3. Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) of E6130

    Time frame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)

  4. Area under the serum concentration-time curve from time zero to infinity (AUC(0-inf)) of E6130

    Time frame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)

  5. Apparent terminal phase half-life (t1/2) of E6130

    Time frame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)

Sponsors and collaborators

Lead sponsor

EA Pharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2016
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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