Japanese Healthy Adult Male ParticipantsPhase 1NCT02902978
A Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects
A Phase 1 study testing E6130 in people with Japanese Healthy Adult Male Participants, run by EA Pharma Co., Ltd. at 1 site in Japan.
Trial 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. 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
- Japanese Healthy Adult Male Participants
- What is being tested?
- E6130
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteJapan
- Study dates
- 26 Sep 2016to 17 Aug 2017
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects
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.
Read the detailed description
This study consists of 8 cohorts, Cohorts 1 to 8. Cohorts 1 to 7 are designed as a single-center, single dose, placebo-controlled, randomized, ascending dose, double-blind study. Cohort 8 is designed as a single-center, single dose, randomized, open-label, two-group, two-period crossover study. Cohort 8 will be initiated after Cohorts 1 to 7 are completed.
- Conditions
- Japanese Healthy Adult Male Participants
- Being tested
- E6130, Placebo
- Keywords
- E6130, Japanese 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
PlaceboDrug
E6130 matched placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: E6130 |
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 1 to 7), Days 1 to 21 (Cohort 8)
Secondary outcomes (5)
Maximum observed serum concentration (Cmax) of E6130
Measured: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
Time to Cmax (Tmax) of E6130
Measured: 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
Measured: 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
Measured: 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
Measured: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start26 Sep 2016
- Primary completion17 Aug 2017
- Study completion17 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Japanese Healthy Adult Male 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- EA Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902978
- Sponsor's protocol ID
- E6130-J081-001
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2016
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT02902978
- Acronym / sponsor ID
- E6130-J081-001
- Conditions
- Japanese Healthy Adult Male Participants
- Keywords
- E6130, Japanese healthy adult male participants, Phase 1, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 17 Aug 2017 (actual)
- Study completion
- 17 Aug 2017 (actual)
- First posted
- 16 Sep 2016 (estimated)
- 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 a single dose of E6130 in Japanese healthy adult male participants.
Detailed description
This study consists of 8 cohorts, Cohorts 1 to 8. Cohorts 1 to 7 are designed as a single-center, single dose, placebo-controlled, randomized, ascending dose, double-blind study. Cohort 8 is designed as a single-center, single dose, randomized, open-label, two-group, two-period crossover study. Cohort 8 will be initiated after Cohorts 1 to 7 are completed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 to 7 | Experimental | Drug: E6130, Drug: PlaceboParticipants will receive a single dose of E6130 or placebo, administered in a dose-ascending manner under the fasted condition. |
| Cohort 8 | Experimental | Drug: E6130Participants 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. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| E6130 | Drug | Cohort 1 to 7, Cohort 8 |
| PlaceboE6130 matched placebo | Drug | Cohort 1 to 7 |
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 1 to 7), Days 1 to 21 (Cohort 8)
5 secondary outcomes
Maximum observed serum concentration (Cmax) of E6130
Time frame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
Time to Cmax (Tmax) of E6130
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Days 1 to 6 (Cohort 1 to 7), Days 1 to 6 and 8 to 13 (Cohort 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E6130 in people with Japanese Healthy Adult Male Participants, run by EA Pharma Co., Ltd. at 1 site in Japan.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 1 to 7), Days 1 to 21 (Cohort 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2018.