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

NCT03390647 | Withdrawn Phase 1

• 1 other identifier: E6130-CP2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy Participants

Keywords

E6130; 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 A1); Days 1 to 12 (Cohorts A2 to A4); Days 1 to 8 (Cohort B1)

Secondary Outcomes (8)

• 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)

Study Arms (3)

Cohort A1

EXPERIMENTAL

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

Cohort B1

EXPERIMENTAL

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

Drug: E6130; Drug: Placebo

Cohorts A2-A4

EXPERIMENTAL

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; Drug: Placebo

Interventions

E6130 DRUG

Oral dose

Cohort A1; Cohort B1; Cohorts A2-A4

Placebo DRUG

E6130-matched placebo

Cohort B1; Cohorts A2-A4

Eligibility Criteria

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

You may qualify if:

• Participants must meet all of the following criteria to be included in this study.
• 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
• Has voluntarily consented, in writing, to participate in this study
• Has been thoroughly briefed on the conditions for participation in the study, and are willing and able to comply with the conditions

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from this study.
• History of surgical treatment 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, electrocardiogram 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 Design

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

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 4, 2018
• Study Start: December 21, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 31, 2018

Record last verified: 2018-07