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

A Phase 1 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.

Study Overview

• Status: Completed
• Conditions: Japanese Healthy Adult Male Participants
• Intervention / Treatment: Drug: E6130; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Sumida, Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: EA Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2016
• Primary Completion (Actual): August 17, 2017
• Study Completion (Actual): August 17, 2017

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Phase 1; E6130; Japanese healthy adult male participants
• Other Study ID Numbers: E6130-J081-001