HealthyPhase 1NCT02146261
A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male Subjects
A Phase 1 study testing E6011 in people with Healthy, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and tolerability of a single subcutaneous administration of E6011. 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
- What is being tested?
- E6011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2013to Apr 2014
- 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
- Non-smoking Japanese male subjects aged greater than or equal to 20 to less than 45 years
- BMI at screening is greater than or equal to 18.5 kg/m2 to less than 25.0 kg/m2
- Males who have not had a successful vasectomy and their female partners must agree to practice highly effective contraception throughout the study period
Who cannot join
- Has been treated with biologic product(s) (except for immunoglobulin)
- Has received immunoglobulin or blood preparation within 6 months before the study treatment
- Has received inoculation within 4 weeks before the study treatment
- Has a history of autoimmune disease or immunodeficiency
- Has a history of clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis
- Has a history of acute myocardial infarction, cerebral infarction, cerebral hemorrhage, or arteriosclerosis obliterans
Show all 14Show fewer
- With gross hematuria, occult bleeding in urine of greater than or equal to 1+ and urine protein of greater than or equal to 1+, or either of greater than or equal to 2+ is found at screening
- Has a clinically significant vasculitis (e.g., mononeuritis multiplex)
- Known to be positive for human immunodeficiency virus antigen/antibody (HIV antigen/antibody), hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B core virus antibody (HBc antibody), hepatitis B virus (HBV) DNA, hepatitis C virus antibody (HCV antibody), human T cell lymphotropic virus type 1 antibody (HTVL-1 antibody), or syphilis serology test positive at screening.
- Known to be positive for tuberculosis test (T-spot.TB Test or QuantiFERON TB Gold Test) at screening.
- Treated with ethical drug (except for disinfectants, eye drops) within 4 weeks before the study treatment.
- Treated with non-prescription drug (except for disinfectants, eye drops) within 2 weeks before the study treatment.
- Has participated in another clinical trial and received an investigational drug or device within 16 weeks before the study treatment.
- Received blood transfusion within 1 year, 400 mL or more whole blood donation within 12 weeks, or 200 mL or more whole blood donation within 4 weeks, or blood constituent donation within 2 weeks before the study treatment.
Trial locations and contacts
1 site in 1 country.
About this study
This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will be randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per cohort, six subjects will receive the single subcutaneous E6011 administration and two subjects will receive the single subcutaneous placebo administration.
Read the detailed description
This study consists of Screening Period, Observation Period, In-patient Period, and Follow-up Period. Screening assessments will be performed within 28 to 2 days before starting the study treatment, and Observation Period assessments will be performed on a day before starting the study treatment to confirm the eligibility of study subjects. The eligible subjects will be randomized into either E6011 arm or placebo arm using the drug allocation list prepared by the random code statistician. Each subjects dosing interval will be at least a 30-minutes.
- Conditions
- Healthy
- Being tested
- E6011, Placebo
- Keywords
- Volunteers, Japanese, Males
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6011Drug
Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg)
PlaceboDrug
Subcutaneous administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subcutaneous administration of E6011 50 mg Receives: Drug: E6011 |
| 2 | Experimental | Subcutaneous administration of E6011 100 mg Receives: Drug: E6011 |
| 3 | Experimental | Subcutaneous administration of E6011 200 mg Receives: Drug: E6011 |
| 4 | Experimental | Subcutaneous administration of E6011 400 mg Receives: Drug: E6011 |
| 5 | Placebo comparator | Subcutaneous administration of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of E6011: Maximum Concentration (Cmax)
Measured: Up to 10 Weeks
Pharmacokinetics of E6011: Time to attain Cmax (tmax)
Measured: Up to 10 Weeks
Pharmacokinetics of E6011: Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-t)
Measured: Up to 10 Weeks
Pharmacokinetics of E6011: Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time AUC(0-inf)
Measured: Up to 10 Weeks
Pharmacokinetics of E6011: Elimination half-life (t1/2)
Measured: Up to 10 Weeks
Pharmacokinetics of E6011: CL/F
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-?).
Measured: Up to 10 Weeks
Pharmacokinetics of E6011: Apparent Volume of Distribution of Azacitidine (Vz/F)
Measured: Up to 10 Weeks
Safety and Tolerability of E6011
The safety will be assessed based on all adverse events (AEs), clinical laboratory test, vital signs, body weight, physical finding, administration site finding, electrocardiography and chest xray.
Measured: Up to 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146261
- Sponsor's protocol ID
- E6011-J081-002
- Status last verified
- May 2014
- First submitted
- 21 May 2014
- Last updated
- 22 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Single-dose Subcutaneous E6011 in Japanese Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT02146261
- Acronym / sponsor ID
- E6011-J081-002
- Conditions
- Healthy
- Keywords
- Volunteers, Japanese, Males
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 May 2014 (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.
This study (Protocol No. E6011-J081-002) is a single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate mainly the safety and tolerability of a single subcutaneous administration of E6011. A total of 32 subjects will be randomized into four cohorts (50, 100, 200 and 400 mg groups). Of eight subjects per cohort, six subjects will receive the single subcutaneous E6011 administration and two subjects will receive the single subcutaneous placebo administration.
Detailed description
This study consists of Screening Period, Observation Period, In-patient Period, and Follow-up Period. Screening assessments will be performed within 28 to 2 days before starting the study treatment, and Observation Period assessments will be performed on a day before starting the study treatment to confirm the eligibility of study subjects. The eligible subjects will be randomized into either E6011 arm or placebo arm using the drug allocation list prepared by the random code statistician. Each subjects dosing interval will be at least a 30-minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: E6011Subcutaneous administration of E6011 50 mg |
| 2 | Experimental | Drug: E6011Subcutaneous administration of E6011 100 mg |
| 3 | Experimental | Drug: E6011Subcutaneous administration of E6011 200 mg |
| 4 | Experimental | Drug: E6011Subcutaneous administration of E6011 400 mg |
| 5 | Placebo comparator | Drug: PlaceboSubcutaneous administration of placebo |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-smoking Japanese male subjects aged greater than or equal to 20 to less than 45 years
- BMI at screening is greater than or equal to 18.5 kg/m2 to less than 25.0 kg/m2
- Males who have not had a successful vasectomy and their female partners must agree to practice highly effective contraception throughout the study period
Key exclusion criteria (14 listed)
- Has been treated with biologic product(s) (except for immunoglobulin)
- Has received immunoglobulin or blood preparation within 6 months before the study treatment
- Has received inoculation within 4 weeks before the study treatment
- Has a history of autoimmune disease or immunodeficiency
- Has a history of clinically significant angioedema, hematemesis, anal hemorrhage, or hemoptysis
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 |
|---|---|---|
| E6011Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg) | Drug | 1, 2, 3, 4 |
| PlaceboSubcutaneous administration of placebo | Drug | 5 |
Primary outcome
Pharmacokinetics of E6011: Maximum Concentration (Cmax)
Time frame: Up to 10 Weeks
Pharmacokinetics of E6011: Time to attain Cmax (tmax)
Time frame: Up to 10 Weeks
Pharmacokinetics of E6011: Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-t)
Time frame: Up to 10 Weeks
Pharmacokinetics of E6011: Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time AUC(0-inf)
Time frame: Up to 10 Weeks
Pharmacokinetics of E6011: Elimination half-life (t1/2)
Time frame: Up to 10 Weeks
Pharmacokinetics of E6011: CL/F
Time frame: Up to 10 Weeks
Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-?).
Pharmacokinetics of E6011: Apparent Volume of Distribution of Azacitidine (Vz/F)
Time frame: Up to 10 Weeks
Safety and Tolerability of E6011
Time frame: Up to 10 Weeks
The safety will be assessed based on all adverse events (AEs), clinical laboratory test, vital signs, body weight, physical finding, administration site finding, electrocardiography and chest xray.
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 22 Oct 2014.
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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 E6011 in people with Healthy, run by Eisai 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 14 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 22 Oct 2014. 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. Some participants in this study may receive a placebo. 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?
Pharmacokinetics of E6011: Maximum Concentration (Cmax) (time frame: Up to 10 Weeks). The study lists 8 primary outcomes in all. 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 22 Oct 2014.