A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Adult Male Participants

EA Pharma

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: E6130

Study type: Interventional

Funder types: Industry

Identifiers

NCT03390647

E6130-CP2

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of E6130 in Japanese healthy adult male participants.

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Participants must meet all of the following criteria to be included in this study.

1. Japanese or Caucasian 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 are willing and able to comply with the conditions

Exclusion criteria

Participants who meet any of the following criteria will be excluded from this study.

1. History of surgical treatment 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, electrocardiogram 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

Cohort A1

Experimental group

Description:

Japanese participants will receive a single oral dose of E6130 on Day 1 and Day 7 administered in the specified order (fasted/fed or fed/fasted) to evaluate the food effect.

Treatment:

Drug: E6130

Cohort B1

Experimental group

Description:

Caucasian participants will receive a single oral dose of either E6130 or placebo on Day 1.

Treatment:

Drug: E6130

Drug: Placebo

Cohorts A2-A4

Experimental group

Description:

Japanese participants will receive multiple oral doses of E6130 or placebo on Days 1 to 5, administered in a randomized, dose-ascending manner.

Treatment:

Drug: E6130

Drug: Placebo