Healthy VolunteersPhase 1NCT02268838
Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects
A Phase 1 study testing E6007 in people with Healthy Volunteers, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study. This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This study consists of 5 steps, 1 to 5. 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 Volunteers
- What is being tested?
- E6007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2014to Nov 2015
- 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
- Subjects must meet all of the following criteria to be included in this study:
- Healthy Japanese male subjects aged 20 to 44 years at the time of informed consent.
- 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
- Subjects who meet any of the following criteria will be excluded from this study:
- Has a clinically significant medical condition requiring treatment within 8 weeks before the initial study drug administration, or a history of clinically significant infection requiring treatment within 4 weeks before the initial drug administration.
- History of surgical treatment such as resection of the liver, kidney, or Gastrointestinal tract, that may affect the Pharmacokinetic profiles of study drugs.
- Ineligible for study participation in the opinion of the investigator or sub-investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects
This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study. This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This study consists of 5 steps, 1 to 5. In steps 1 to 4 (at ascending doses of 50, 100, 200, and 400 mg), subjects will be randomly assigned in a 6:2 ratio (E6007: placebo) to receive single dose of the study drug under fasted condition. Following 3 days of washout period, subject will receive the study drug once daily for 7 days starting on the fifth day from the single dose administration.
For step 3 (200 mg), subjects will subsequently have at least 17 days of washout period before being escalated to step 5 (200 mg) to receive single dose of E6007 under fed condition, to evaluate food effect of the study drug.
- Conditions
- Healthy Volunteers
- Being tested
- E6007, E6007 matching placebo
- Keywords
- E6007, Healthy Japanese male subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6007Drug
E6007 matching placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 50 mg E6007 fasted condition | Experimental | E6007 50mg or E6007 matching placebo x 1, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period. Receives: Drug: E6007; Drug: E6007 matching placebo |
| 100 mg E6007 fasted condition | Experimental | E6007 50mg or E6007 matching placebo x 2, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period. Receives: Drug: E6007; Drug: E6007 matching placebo |
| 200 mg E6007 fasted condition | Experimental | E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period. Receives: Drug: E6007; Drug: E6007 matching placebo |
| 400 mg E6007 fasted condition | Experimental | E6007 50mg or E6007 matching placebo x 8, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period. Receives: Drug: E6007; Drug: E6007 matching placebo |
| 200 mg E6007 fed condition | Experimental | E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fed condition. Drug administration on 1 day (Day 1). Receives: Drug: E6007; Drug: E6007 matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of E6007 as a measure of Adverse events
Measured: Screening and up to 17 days after last administration of drug
Plasma E6007 concentration over time period - Cmax (maximum concentration)
Measured: Up to 15 days
Plasma E6007 concentration over time period - tmax (Time to achieve maximum concentration (Cmax))
Measured: Up to 15 days
Plasma E6007 concentration over time period - AUC (0-t) (Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration)
Measured: Up to 15 days
Plasma E6007 concentration over time period - AUC (0-inf) (AUC extrapolated to infinity)
Measured: Up to 15 days
Plasma E6007 concentration over time period - t1/2 (Terminal phase half-life)
Measured: Up to 15 days
Plasma E6007 concentration over time period - CL/F (Apparent clearance)
Measured: Up to 15 days
Plasma E6007 concentration over time period - Vz/F (Apparent volume of distribution)
Measured: Up to 15 days
Plasma E6007 concentration over time period - Css,max (maximum steady state concentration)
Measured: Up to 15 days
Plasma E6007 concentration over time period - AUC (0-tau) (AUC from time zero to time tau over a dosing interval at steady state)
Measured: Up to 15 days
Secondary outcomes (3)
Dose proportionality under fasted conditions with Cmax, AUC (0-t), AUC(0-inf), Cssmax and AUC(0-t)
Measured: Up to 15 days
Geometric mean proportion (fed:fasted) of Cmax, AUC(0-t) and AUC(0-inf) for 200mg E6007 dose
Measured: Up to 5 days
Evaluate relationship between E6007 plasma concentrations and electrocardiogram (ECG) parameter (QTcF)
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 24 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
- NCT02268838
- Sponsor's protocol ID
- E6007-J081-002
- Status last verified
- Dec 2015
- First submitted
- 16 Oct 2014
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT02268838
- Acronym / sponsor ID
- E6007-J081-002
- Conditions
- Healthy Volunteers
- Keywords
- E6007, Healthy Japanese male subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Oct 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 is a single-center, placebo-controlled, randomized, ascending dose, double-blind study. This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This study consists of 5 steps, 1 to 5. In steps 1 to 4 (at ascending doses of 50, 100, 200, and 400 mg), subjects will be randomly assigned in a 6:2 ratio (E6007: placebo) to receive single dose of the study drug under fasted condition. Following 3 days of washout period, subject will receive the study drug once daily for 7 days starting on the fifth day from the single dose administration.
For step 3 (200 mg), subjects will subsequently have at least 17 days of washout period before being escalated to step 5 (200 mg) to receive single dose of E6007 under fed condition, to evaluate food effect of the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 50 mg E6007 fasted condition | Experimental | Drug: E6007, Drug: E6007 matching placeboE6007 50mg or E6007 matching placebo x 1, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period. |
| 100 mg E6007 fasted condition | Experimental | Drug: E6007, Drug: E6007 matching placeboE6007 50mg or E6007 matching placebo x 2, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period. |
| 200 mg E6007 fasted condition | Experimental | Drug: E6007, Drug: E6007 matching placeboE6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period. |
| 400 mg E6007 fasted condition | Experimental | Drug: E6007, Drug: E6007 matching placeboE6007 50mg or E6007 matching placebo x 8, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period. |
| 200 mg E6007 fed condition | Experimental | Drug: E6007, Drug: E6007 matching placeboE6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fed condition. Drug administration on 1 day (Day 1). |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Japanese male subjects aged 20 to 44 years at the time of informed consent.
- 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)
- Has a clinically significant medical condition requiring treatment within 8 weeks before the initial study drug administration, or a history of clinically significant infection requiring treatment within 4 weeks before the initial drug administration.
- History of surgical treatment such as resection of the liver, kidney, or Gastrointestinal tract, that may affect the Pharmacokinetic profiles of study drugs.
- Ineligible for study participation in the opinion of the investigator or sub-investigator.
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 |
|---|---|---|
| E6007 | Drug | 100 mg E6007 fasted condition, 200 mg E6007 fasted condition, 200 mg E6007 fed condition, 400 mg E6007 fasted condition, 50 mg E6007 fasted condition |
| E6007 matching placebo | Drug | 100 mg E6007 fasted condition, 200 mg E6007 fasted condition, 200 mg E6007 fed condition, 400 mg E6007 fasted condition, 50 mg E6007 fasted condition |
Primary outcome
Safety and tolerability of E6007 as a measure of Adverse events
Time frame: Screening and up to 17 days after last administration of drug
Plasma E6007 concentration over time period - Cmax (maximum concentration)
Time frame: Up to 15 days
Plasma E6007 concentration over time period - tmax (Time to achieve maximum concentration (Cmax))
Time frame: Up to 15 days
Plasma E6007 concentration over time period - AUC (0-t) (Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration)
Time frame: Up to 15 days
Plasma E6007 concentration over time period - AUC (0-inf) (AUC extrapolated to infinity)
Time frame: Up to 15 days
Plasma E6007 concentration over time period - t1/2 (Terminal phase half-life)
Time frame: Up to 15 days
Plasma E6007 concentration over time period - CL/F (Apparent clearance)
Time frame: Up to 15 days
Plasma E6007 concentration over time period - Vz/F (Apparent volume of distribution)
Time frame: Up to 15 days
Plasma E6007 concentration over time period - Css,max (maximum steady state concentration)
Time frame: Up to 15 days
Plasma E6007 concentration over time period - AUC (0-tau) (AUC from time zero to time tau over a dosing interval at steady state)
Time frame: Up to 15 days
3 secondary outcomes
Dose proportionality under fasted conditions with Cmax, AUC (0-t), AUC(0-inf), Cssmax and AUC(0-t)
Time frame: Up to 15 days
Geometric mean proportion (fed:fasted) of Cmax, AUC(0-t) and AUC(0-inf) for 200mg E6007 dose
Time frame: Up to 5 days
Evaluate relationship between E6007 plasma concentrations and electrocardiogram (ECG) parameter (QTcF)
Time frame: Up to 15 days
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 20 Jan 2016.
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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 E6007 in people with Healthy Volunteers, 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 4 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 20 Jan 2016. 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?
Safety and tolerability of E6007 as a measure of Adverse events (time frame: Screening and up to 17 days after last administration of drug). The study lists 10 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 20 Jan 2016.