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

NCT02902978 | Completed Phase 1

• 1 other identifier: E6130-J081-001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Japanese Healthy Adult Male Participants

Keywords

E6130; Japanese healthy adult male participants; Phase 1; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Study Arms (2)

Cohort 1 to 7

EXPERIMENTAL

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

Drug: E6130; Drug: Placebo

Cohort 8

EXPERIMENTAL

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

Interventions

E6130 DRUG

Cohort 1 to 7; Cohort 8

Placebo DRUG

E6130 matched placebo

Cohort 1 to 7

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EA Pharma Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Sumida City, Tokyo, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: September 26, 2016
• Primary Completion: August 17, 2017
• Study Completion: August 17, 2017
• Last Updated: September 6, 2018

Record last verified: 2017-09

Locations

JP (1)