Healthy ParticipantsPhase 1NCT03390647

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

A Phase 1 study testing E6130 in people with Healthy Participants, run by EA Pharma Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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. Read more about this study

Who is it for?: Ages 20 to 44 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: E6130
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: 21 Dec 2017to Mar 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 44 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

Conditions: Healthy Participants
Being tested: E6130, Placebo
Keywords: E6130, Healthy adult male participants, Phase 1, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E6130Drug
Oral dose
PlaceboDrug
E6130-matched placebo

Study groups in NCT03390647
Study group	Role	What they receive
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. Receives: Drug: E6130
Cohort B1	Experimental	Caucasian participants will receive a single oral dose of either E6130 or placebo on Day 1. Receives: 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. Receives: Drug: E6130; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability
Measured: 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
Measured: 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
Measured: Days 1 to 7 (Cohorts A2 to A4)
Time to Cmax (tmax) of E6130
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Days 1 to 7 (Cohorts A2 to A4)
Terminal elimination phase half-life (t1/2) of E6130
Measured: Days 1 to 7 (Cohorts A2 to A4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 2017Mar 2019

First posted4 Jan 2018
Study start21 Dec 2017
Primary completionMar 2019 (estimated)
Study completionMar 2019 (estimated)

Why it stopped: Decision of Sponsor

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03390647
Sponsor's protocol ID: E6130-CP2
Status last verified: Jul 2018
First submitted: 28 Dec 2017
Last updated: 31 Jul 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Clinical Study of E6130 - Clinical Pharmacology Study in Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT03390647
Acronym / sponsor ID: E6130-CP2
Conditions: Healthy Participants
Keywords: E6130, Healthy adult male participants, Phase 1, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Decision of Sponsor
Enrolment: 0 participants (actual)
Lead sponsor: EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 21 Dec 2017 (actual)
Primary completion: Mar 2019 (estimated)
Study completion: Mar 2019 (estimated)
First posted: 4 Jan 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Cohort A1	Experimental	Drug: E6130Japanese 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.
Cohort B1	Experimental	Drug: E6130, Drug: PlaceboCaucasian participants will receive a single oral dose of either E6130 or placebo on Day 1.
Cohorts A2-A4	Experimental	Drug: E6130, Drug: PlaceboJapanese participants will receive multiple oral doses of E6130 or placebo on Days 1 to 5, administered in a randomized, dose-ascending manner.

Who may qualify

Ages: 20 to 44 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
E6130Oral dose	Drug	Cohort A1, Cohort B1, Cohorts A2-A4
PlaceboE6130-matched placebo	Drug	Cohort B1, Cohorts A2-A4

Primary outcome

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)

8 secondary outcomes

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)
Maximum observed serum concentration at steady state (Css, max) of E6130
Time frame: Days 1 to 7 (Cohorts A2 to A4)
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)
Time to Cmax at steady state (tss, max) of E6130
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Days 1 to 7 (Cohorts A2 to A4)
Terminal elimination phase half-life (t1/2) of E6130
Time frame: Days 1 to 7 (Cohorts A2 to A4)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.

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RecruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing E6130 in people with Healthy Participants, run by EA Pharma Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03390647.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.