HealthyPhase 1NCT01450839
E2022 Patch Formulation Multiple Dose Study
A Phase 1 study testing E2022 in people with Healthy, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
This study is to evaluate the safety and tolerability of a E2022 16 mg tape when applied repeatedly for 17 days to healthy elderly Japanese male subjects, using E2022 placebo tape as the control. Read more about this study
- Who is it for?
- Ages 65 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- E2022
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2011to Feb 2012
- 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 65 years and older
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects who are non-smoking males (not smoking for at least 4 weeks before the administration of the investigational product in Period I) 65 years or older at the time of giving informed consent
- Subjects whose body mass index (BMI) is 18.5 kg/m^2 to less than 28.0 kg/m^2 at the screening
- Subjects who give voluntary written consent to participate in the study
- Subjects who have been fully informed of matters subjects are required to observe during the study and can, and are willing to, comply with the rules.
Who cannot join
- Subjects with a history of treatment-requiring disease within 8 weeks before administration of the investigational product in Period I or history of infection within 4 weeks before administration of the investigational product in Period I
- Subjects who have, within 4 weeks before administration of the investigational product in Period I, a disease that might affect the evaluation of the investigational product, such as mental, gastrointestinal, hepatic, renal, respiratory, endocrine, hematological, nervous, or cardiovascular diseases, and inborn error of metabolism
- Subjects with a history of surgical treatment of the gastrointestinal tract (e.g., resection of the liver, kidney, gastrointestinal tract, etc.) that may affect the pharmacokinetics of the investigational product
- Subjects with a history of treatment-requiring drug or food allergy or with seasonal allergy at the screening
- Subjects with a change in body weight of more than 10% at 1 day before investigational product administration in Period I, compared with that observed at the screening
- Subjects with clinically significant, treatment-requiring symptoms or impairment of organ function, judging from the subjective symptoms/objective findings, vital signs, 12-lead ECG, or laboratory test performed during the period from the screening to immediately before investigational product administration in Period I
Show all 23Show fewer
- Subjects with QTc>450 ms on 12-lead ECG performed at the screening or immediately before investigational product administration in Period I
- Subjects who are positive for human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or qualitative syphilis test, at the screening
- Subjects with a history of, or suspected diagnosis of, drug or alcohol dependence or Subjects who are positive for urine drug test at the screening or 1 day before investigational product administration in Period I
- Subjects who took caffeine-containing or alcoholic beverage within 72 hours before investigational product administration in Period I
- Subjects who took, within 2 weeks before investigational product administration in Period I, nutritional supplements, herb-containing drug preparations (including Chinese medicines) or other foods or beverages (e.g., grapefruit-containing foods or beverages) that may affect drug-metabolizing enzymes or transporters
- Subjects who took drug preparations containing St. John's wort within 4 weeks before investigational product administration in Period I
- Subjects who took prescription drugs within 4 weeks before investigational product administration in Period I
- Subjects who took non-prescription drugs within 2 weeks before investigational product administration in Period I
- Subjects who participated in another clinical study within 16 weeks before investigational product administration in Period I and used an investigational product or medical device
- Subjects who received blood transfusion within 12 weeks, had 400 mL or more whole blood collected within 12 weeks, had 200 mL or more whole blood collected within 4 weeks, or donated blood components within 2 weeks, before investigational product administration in Period I
- Subjects who performed strenuous exercise at a frequency of 5 days or more per week or who performed, even once, a strenuous exercise lasting 1 hour or more, within 2 weeks before admission for Period I
- Subjects with past or current clinical signs of cutaneous hypersensitivity or atopic dermatitis to external medicines
- Subjects in whom the investigational product and the fixing sheet cannot be applied to 6 or more non-overlapping sites on the back (except the vertebral region and the site around the angulus inferior scapulae) by rotation method
- Subjects with excessive hair at the application site (back)
- Subjects with conditions at the application site (back), such as skin diseases (e.g., eczema, dermatitis and pigmentary abnormality), external injuries, and scars, that may affect the evaluation of skin symptom
- Subjects who, or whose partners, are not willing to take reliable contraceptive measures until the completion of the post-treatment examination
- Subjects who are judged by the investigator or subinvestigator to be inappropriate as subjects of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E2022 Patch Formulation Multiple Dose Phase I Study
This study is to evaluate the safety and tolerability of a E2022 16 mg tape when applied repeatedly for 17 days to healthy elderly Japanese male subjects, using E2022 placebo tape as the control.
- Conditions
- Healthy
- Being tested
- E2022, Placebo
- Keywords
- Transdermal Administration, Japanese, elderly, male, volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2022Drug
The treatment period consists of 2 periods, Period I and Period II. In Period I, one 5 mg E2020 tablet will be administered in a single dose. In Period II, the tape containing 16 mg E2022 (which corresponds to one 5 mg E2020 tablet) will be applied repeatedly for 17 days. A washout period of at least 8 days will be allowed between the day of single dose administration in Period I and the first day of repeated application in Period II. A post-treatment examination will be performed at least 21 days after the last removal of the investigational product in Period II.
PlaceboDrug
Matching Placebo tablets and tape
| Study group | Role | What they receive |
|---|---|---|
| E2020 5 mg tablet and tape | Experimental | Not described Receives: Drug: E2022 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite (or Profile) of Pharmacokinetics
Cmax, Area Under Curve, Tmax
Measured: predose, 0,1, 2, 3, 4, 6, 8,1 2, 24, 48, 72, 96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionFeb 2012
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hidetaka Hiramatsu, Study director, Neuroscience Cliical Development Section, Japan /Asia Clinical Research PCU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450839
- Sponsor's protocol ID
- E2022-J081-002
- Status last verified
- May 2012
- First submitted
- 4 Oct 2011
- Last updated
- 1 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E2022 Patch Formulation Multiple Dose Phase I Study
- ClinicalTrials.gov ID
- NCT01450839
- Acronym / sponsor ID
- E2022-J081-002
- Conditions
- Healthy
- Keywords
- Transdermal Administration, Japanese, elderly, male, volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 12 Oct 2011 (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 is to evaluate the safety and tolerability of a E2022 16 mg tape when applied repeatedly for 17 days to healthy elderly Japanese male subjects, using E2022 placebo tape as the control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E2020 5 mg tablet and tape | Experimental | Drug: E2022 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Subjects who are non-smoking males (not smoking for at least 4 weeks before the administration of the investigational product in Period I) 65 years or older at the time of giving informed consent
- Subjects whose body mass index (BMI) is 18.5 kg/m^2 to less than 28.0 kg/m^2 at the screening
- Subjects who give voluntary written consent to participate in the study
- Subjects who have been fully informed of matters subjects are required to observe during the study and can, and are willing to, comply with the rules.
Key exclusion criteria (23 listed)
- Subjects with a history of treatment-requiring disease within 8 weeks before administration of the investigational product in Period I or history of infection within 4 weeks before administration of the investigational product in Period I
- Subjects who have, within 4 weeks before administration of the investigational product in Period I, a disease that might affect the evaluation of the investigational product, such as mental, gastrointestinal, hepatic, renal, respiratory, endocrine, hematological, nervous, or cardiovascular diseases, and inborn error of metabolism
- Subjects with a history of surgical treatment of the gastrointestinal tract (e.g., resection of the liver, kidney, gastrointestinal tract, etc.) that may affect the pharmacokinetics of the investigational product
- Subjects with a history of treatment-requiring drug or food allergy or with seasonal allergy at the screening
- Subjects with a change in body weight of more than 10% at 1 day before investigational product administration in Period I, compared with that observed at the 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 |
|---|---|---|
| E2022The treatment period consists of 2 periods, Period I and Period II. In Period I, one 5 mg E2020 tablet will be administered in a single dose. In Period II, the tape containing 16 mg E2022 (which corresponds to one 5 mg E2020 tablet) will be applied repeatedly for 17 days. A washout period of at least 8 days will be allowed between the day of single dose administration in Period I and the first day of repeated application in Period II. A post-treatment examination will be performed at least 21 days after the last removal of the investigational product in Period II. | Drug | E2020 5 mg tablet and tape |
| PlaceboMatching Placebo tablets and tape | Drug | 2 |
Primary outcome
Composite (or Profile) of Pharmacokinetics
Time frame: predose, 0,1, 2, 3, 4, 6, 8,1 2, 24, 48, 72, 96 hours post-dose
Cmax, Area Under Curve, Tmax
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 1 Jun 2012.
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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.
Hidetaka Hiramatsu study director
Neuroscience Cliical Development Section, Japan /Asia Clinical Research PCU
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 E2022 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 4 inclusion and 23 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 1 Jun 2012. 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?
Composite (or Profile) of Pharmacokinetics (time frame: predose, 0,1, 2, 3, 4, 6, 8,1 2, 24, 48, 72, 96 hours post-dose). 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 1 Jun 2012.