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

A Phase 1 Clinical Study of E6130 - Clinical Pharmacology Study in Healthy Adult Male Subjects

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: E6130; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 1

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort A1; 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.	Drug: E6130; Oral dose
EXPERIMENTAL: Cohort B1; Caucasian participants will receive a single oral dose of either E6130 or placebo on Day 1.	Drug: E6130; Oral dose; Drug: Placebo; E6130-matched placebo
EXPERIMENTAL: Cohorts A2-A4; Japanese participants will receive multiple oral doses of E6130 or placebo on Days 1 to 5, administered in a randomized, dose-ascending manner.	Drug: E6130; Oral dose; Drug: Placebo; E6130-matched placebo

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 A1); Days 1 to 12 (Cohorts A2 to A4); Days 1 to 8 (Cohort B1)

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed serum concentration (Cmax) of E6130	Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)
Maximum observed serum concentration at steady state (Css, max) of E6130	Days 1 to 7 (Cohorts A2 to A4)
Time to Cmax (tmax) of E6130	Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)
Time to Cmax at steady state (tss, max) of E6130	Days 1 to 7 (Cohorts A2 to A4)
Area under the serum concentration-time curve from zero time to the time of last quantifiable concentration (AUC[0-t]) of E6130	Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)
Area under the serum concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) of E6130	Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)
Area under the serum concentration-time curve from zero time to 24 hours (AUC[0-24h]) of E6130	Days 1 to 7 (Cohorts A2 to A4)
Terminal elimination phase half-life (t1/2) of E6130	Days 1 to 7 (Cohorts A2 to A4)

Collaborators and Investigators

• Sponsor: EA Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2017
• Primary Completion (ANTICIPATED): March 1, 2019
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (ACTUAL): January 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Phase 1; E6130; Healthy adult male participants
• Other Study ID Numbers: E6130-CP2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No