Healthy SubjectsPhase 1NCT02289599
A Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese Subjects
A Phase 1 study testing E2307 in people with Healthy Subjects, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
This study will be a single-center, single dose, randomized, double-blind, placebo-controlled study in healthy Japanese male subjects. The study will consist of 2 parts: Part A (young subjects) and Part B (elderly subjects). In Part A sequential cohorts of subjects will be treated with single ascending doses of E2307. Read more about this study
- Who is it for?
- Ages 20 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- E2307
- 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
- Nov 2014to Jul 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 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parts A and B
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
- Part A: Young cohort
- Non-smoking, male subjects age >=20 years and less than 55 years old at the time of informed consent
- Part B: Elderly Cohort
- Non-smoking, male subjects age >=65 years and less than 85 years old at the time of informed consent
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Any history of abdominal surgery that may affect PK profiles of E2307 (eg. hepatectomy, nephrectomy, digestive organ resection)
- Known history of clinically significant drug allergy (at Screening)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese Subjects
This study will be a single-center, single dose, randomized, double-blind, placebo-controlled study in healthy Japanese male subjects. The study will consist of 2 parts: Part A (young subjects) and Part B (elderly subjects). In Part A sequential cohorts of subjects will be treated with single ascending doses of E2307. The maximum tolerated dose (MTD) will be determined in Part A. Part B will be initiated after Part A is completed. In Part B one cohort of healthy elderly subjects will be treated with a single dose of E2307 at one dose level below the MTD. In part A, a total of 56 subjects will be enrolled into 7 cohorts sequentially and randomized 3:1 to receive either E2307 (1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 200 mg, or 300 mg) or placebo. In part B, a total of 8 subjects will be randomized, 6 subjects to a single dose of E2307 and 2 subjects to placebo.
- Conditions
- Healthy Subjects
- Being tested
- E2307, E2307 Matching Placebo
- Keywords
- Healthy Japanese Subjects, E2307, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2307Drug
E2307 Matching PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Part A: 1 mg E2307 (young cohort) | Experimental | E2307 (1 x 1 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule) Receives: Drug: E2307; Drug: E2307 Matching Placebo |
| Part A: 3 mg E2307 (young cohort) | Experimental | E2307 (3 x 1 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules) Receives: Drug: E2307; Drug: E2307 Matching Placebo |
| Part A: 10 mg E2307 (young cohort) | Experimental | E2307 (1 x 10 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule) Receives: Drug: E2307; Drug: E2307 Matching Placebo |
| Part A: 30 mg E2307 (young cohort) | Experimental | E2307 (3 x 10 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules) Receives: Drug: E2307; Drug: E2307 Matching Placebo |
| Part A: 100 mg E2307 (young cohort) | Experimental | E2307 (1 x 100 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule) Receives: Drug: E2307; Drug: E2307 Matching Placebo |
| Part A: 200 mg E2307 (young cohort) | Experimental | E2307 (2 x 100 mg E2307 capsules) or placebo (2 x 1 E2307 matching placebo capsules) Receives: Drug: E2307; Drug: E2307 Matching Placebo |
| Part A: 300 mg E2307 (young cohort) | Experimental | E2307 (3 x 100 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules) Receives: Drug: E2307; Drug: E2307 Matching Placebo |
| Part B: Elderly cohort | Experimental | One dose level below MTD from Part A Receives: Drug: E2307 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events/serious adverse events
Measured: Up to 30 days
Plasma pharmacokinetics (PK) of E2307: Cmax (maximum observed concentration)
Measured: Up to 12 days
Plasma PK of E2307: tmax (time at which the highest drug concentration occurs)
Measured: Up to 12 days
Plasma PK of E2307: AUC(0-t) [area under the concentration (AUC)-time curve from zero time to time of last quantifiable concentration]
Measured: Up to 12 days
Plasma PK of E2307: AUC(0-inf) [area under the concentration-time curve from zero time extrapolated to infinite time]
Measured: Up to 12 days
Plasma PK of E2307: t1/2 (terminal elimination phase half-life)
Measured: Up to 12 days
Plasma PK of E2307: CL/F (apparent total clearance following oral administration)
CL/F are calculated for E2307 only
Measured: Up to 12 days
Plasma PK of E2307: Vz/F (apparent volume of distribution at terminal phase)
Vz/F are calculated for E2307 only
Measured: Up to 12 days
Plasma PK of E2307: AUC ratio (AUC ratio of metabolite to parent)
Measured: Up to 12 days
Urine PK of E2307: Ae (cumulative amount of drug excreted in urine up to 264 hours postdose)
Measured: Up to 12 days
Urine PK of E2307: CLR (renal clearance)
Measured: Up to 12 days
Secondary outcomes (2)
Mean difference in change of mean blood pressure (BP) between E2307 and placebo
Measured: 24 hours predose and continue until 24 hours postdose (Day 2)
QT interval assessment using Holter monitoring
Measured: 24 hours predose through Day 2 (at 24 hours postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- NCT02289599
- Sponsor's protocol ID
- E2307-J081-001
- Status last verified
- Jan 2016
- First submitted
- 10 Nov 2014
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese Subjects
- ClinicalTrials.gov ID
- NCT02289599
- Acronym / sponsor ID
- E2307-J081-001
- Conditions
- Healthy Subjects
- Keywords
- Healthy Japanese Subjects, E2307, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Nov 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 will be a single-center, single dose, randomized, double-blind, placebo-controlled study in healthy Japanese male subjects. The study will consist of 2 parts: Part A (young subjects) and Part B (elderly subjects). In Part A sequential cohorts of subjects will be treated with single ascending doses of E2307. The maximum tolerated dose (MTD) will be determined in Part A. Part B will be initiated after Part A is completed. In Part B one cohort of healthy elderly subjects will be treated with a single dose of E2307 at one dose level below the MTD. In part A, a total of 56 subjects will be enrolled into 7 cohorts sequentially and randomized 3:1 to receive either E2307 (1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 200 mg, or 300 mg) or placebo. In part B, a total of 8 subjects will be randomized, 6 subjects to a single dose of E2307 and 2 subjects to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A: 1 mg E2307 (young cohort) | Experimental | Drug: E2307, Drug: E2307 Matching PlaceboE2307 (1 x 1 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule) |
| Part A: 3 mg E2307 (young cohort) | Experimental | Drug: E2307, Drug: E2307 Matching PlaceboE2307 (3 x 1 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules) |
| Part A: 10 mg E2307 (young cohort) | Experimental | Drug: E2307, Drug: E2307 Matching PlaceboE2307 (1 x 10 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule) |
| Part A: 30 mg E2307 (young cohort) | Experimental | Drug: E2307, Drug: E2307 Matching PlaceboE2307 (3 x 10 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules) |
| Part A: 100 mg E2307 (young cohort) | Experimental | Drug: E2307, Drug: E2307 Matching PlaceboE2307 (1 x 100 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule) |
| Part A: 200 mg E2307 (young cohort) | Experimental | Drug: E2307, Drug: E2307 Matching PlaceboE2307 (2 x 100 mg E2307 capsules) or placebo (2 x 1 E2307 matching placebo capsules) |
| Part A: 300 mg E2307 (young cohort) | Experimental | Drug: E2307, Drug: E2307 Matching PlaceboE2307 (3 x 100 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules) |
| Part B: Elderly cohort | Experimental | Drug: E2307One dose level below MTD from Part A |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Parts A and B
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
- Part A: Young cohort
- Non-smoking, male subjects age >=20 years and less than 55 years old at the time of informed consent
Key exclusion criteria (4 listed)
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
- Any history of abdominal surgery that may affect PK profiles of E2307 (eg. hepatectomy, nephrectomy, digestive organ resection)
- Known history of clinically significant drug allergy (at Screening)
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 |
|---|---|---|
| E2307 | Drug | Part A: 1 mg E2307 (young cohort), Part A: 10 mg E2307 (young cohort), Part A: 100 mg E2307 (young cohort), Part A: 200 mg E2307 (young cohort), Part A: 3 mg E2307 (young cohort), Part A: 30 mg E2307 (young cohort), Part A: 300 mg E2307 (young cohort), Part B: Elderly cohort |
| E2307 Matching Placebo | Drug | Part A: 1 mg E2307 (young cohort), Part A: 10 mg E2307 (young cohort), Part A: 100 mg E2307 (young cohort), Part A: 200 mg E2307 (young cohort), Part A: 3 mg E2307 (young cohort), Part A: 30 mg E2307 (young cohort), Part A: 300 mg E2307 (young cohort) |
Primary outcome
Number of adverse events/serious adverse events
Time frame: Up to 30 days
Plasma pharmacokinetics (PK) of E2307: Cmax (maximum observed concentration)
Time frame: Up to 12 days
Plasma PK of E2307: tmax (time at which the highest drug concentration occurs)
Time frame: Up to 12 days
Plasma PK of E2307: AUC(0-t) [area under the concentration (AUC)-time curve from zero time to time of last quantifiable concentration]
Time frame: Up to 12 days
Plasma PK of E2307: AUC(0-inf) [area under the concentration-time curve from zero time extrapolated to infinite time]
Time frame: Up to 12 days
Plasma PK of E2307: t1/2 (terminal elimination phase half-life)
Time frame: Up to 12 days
Plasma PK of E2307: CL/F (apparent total clearance following oral administration)
Time frame: Up to 12 days
CL/F are calculated for E2307 only
Plasma PK of E2307: Vz/F (apparent volume of distribution at terminal phase)
Time frame: Up to 12 days
Vz/F are calculated for E2307 only
Plasma PK of E2307: AUC ratio (AUC ratio of metabolite to parent)
Time frame: Up to 12 days
Urine PK of E2307: Ae (cumulative amount of drug excreted in urine up to 264 hours postdose)
Time frame: Up to 12 days
Urine PK of E2307: CLR (renal clearance)
Time frame: Up to 12 days
2 secondary outcomes
Mean difference in change of mean blood pressure (BP) between E2307 and placebo
Time frame: 24 hours predose and continue until 24 hours postdose (Day 2)
QT interval assessment using Holter monitoring
Time frame: 24 hours predose through Day 2 (at 24 hours postdose)
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 18 Jan 2016.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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 E2307 in people with Healthy Subjects, 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 7 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 18 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?
Number of adverse events/serious adverse events (time frame: Up to 30 days). The study lists 11 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 18 Jan 2016.