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WithdrawnNCT03390647Updated Jul 31, 2018

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

A Phase 1 interventional study of E6130 and Placebo in Healthy Participants, sponsored by EA Pharma Co., Ltd.. Withdrawn. Open to male participants aged 20 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-31.

Sponsored by EA Pharma Co., Ltd. · Phase 1, Interventional, and Basic science

Why this study was withdrawn
Decision of Sponsor
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
20 Years to 44 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Participants

Keywords

  • E6130
  • Healthy adult male participants
  • Phase 1
  • Pharmacokinetics
03

Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

  • Experimental
    Cohort B1

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

    Drug: E6130 · Drug: 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 · Drug: Placebo

Interventions

  • DrugE6130

    Oral dose

  • DrugPlacebo

    E6130-matched placebo

05

What researchers measure

Primary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability

    Time frame: Days 1 to 14 (Cohort A1); Days 1 to 12 (Cohorts A2 to A4); Days 1 to 8 (Cohort B1)

Secondary outcomes

  1. Maximum observed serum concentration (Cmax) of E6130

    Time frame: Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)

  2. Maximum observed serum concentration at steady state (Css, max) of E6130

    Time frame: Days 1 to 7 (Cohorts A2 to A4)

  3. Time to Cmax (tmax) of E6130

    Time frame: Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)

  4. Time to Cmax at steady state (tss, max) of E6130

    Time frame: Days 1 to 7 (Cohorts A2 to A4)

  5. Area under the serum concentration-time curve from zero time to the time of last quantifiable concentration (AUC[0-t]) of E6130

    Time frame: Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)

  6. Area under the serum concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) of E6130

    Time frame: Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1)

  7. Area under the serum concentration-time curve from zero time to 24 hours (AUC[0-24h]) of E6130

    Time frame: Days 1 to 7 (Cohorts A2 to A4)

  8. Terminal elimination phase half-life (t1/2) of E6130

    Time frame: Days 1 to 7 (Cohorts A2 to A4)

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03390647
Lead sponsor
EA Pharma Co., Ltd.
Responsible party
Sponsor
First posted
Jan 4, 2018
Start date
Dec 21, 2017
Primary completion
Mar 2019 (estimated)
Completion
Mar 2019 (estimated)
Last update
Jul 31, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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