Healthy Elderly MalePhase 1NCT01843556
A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals in Japanese Healthy Elderly Males
A Phase 1 study testing E2022 Tape Formulation in people with Healthy Elderly Male, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and pharmacokinetics. 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 Elderly Male
- What is being tested?
- E2022 Tape Formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2012to Jun 2013
- 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
- Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older at informed consent
- BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2
- Written informed consent
- Given full explanation of this study and is willing to and able to comply with the protocol requirements
Who cannot join
- Have a current or past history of disorder requiring medical treatment within 8 weeks before the first application or infection within 4 weeks before the first application
- Have a disorder within 4 weeks before the first application which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological or cardiovascular system, or congenital metabolic abnormality
- Have a history of gastrointestinal surgery (e.g., liver, kidney, digestive tract) which affects the pharmacokinetics of study drug,
- Have a history of treatment-requiring drug or food allergy or seasonal allergy at screening
- Had caffeine-containing food or drink or alcohol within 72 hours before study drug application in Period I
- Had nutritional supplements, herbal preparations (including oriental medicines) or others (e.g., grapefruit-containing food or beverage) which may affect drug metabolizing enzymes and transporters, within 1 weeks before Period I
Show all 10Show fewer
- Have used liquid products (including cosmetics) on study application sites (back, upper limb, chest), patch, tape or bandage, within 4 weeks before Period 1
- Present or past clinical signs of skin hypersensitivity to topical product or atopic dermatitis
- Excessively hairy or have shaved at application sites (back, upper limb, chest) within 4 weeks before Period 1
- Eczema, dermatitis, abnormal pigmentation, injury, or scar at application sites which may affect the evaluation of skin symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals
A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and pharmacokinetics.
- Conditions
- Healthy Elderly Male
- Being tested
- E2022 Tape Formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2022 Tape FormulationDrug
Also called Donepezil
E2022 tape formulation applied to different application sites and at different intervals in Japanese healthy elderly males
| Study group | Role | What they receive |
|---|---|---|
| E2022 Tape Formulation | Experimental | Not described Receives: Drug: E2022 Tape Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and frequency of adverse events
Measured: 168 hours after the end of application
Secondary outcomes (4)
Maximal Drug Concentration (CMax)
Measured: 216 hours after the end of application
Area Under the Plasma Concentration-Time Curve (AUC)
Measured: 216 hours after the end of application
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 216 hours after the end of application
Plasma Decay Half-Life (t1/2)
Measured: 216 hours after the end of application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Elderly MaleStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hidetaka Hiramatsu, Study director, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843556
- Sponsor's protocol ID
- E2022-J081-003
- Status last verified
- Feb 2014
- First submitted
- 25 Apr 2013
- Last updated
- 18 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals
- ClinicalTrials.gov ID
- NCT01843556
- Acronym / sponsor ID
- E2022-J081-003
- Conditions
- Healthy Elderly Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Apr 2013 (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.
A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E2022 Tape Formulation | Experimental | Drug: E2022 Tape Formulation |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older at informed consent
- BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2
- Written informed consent
- Given full explanation of this study and is willing to and able to comply with the protocol requirements
Key exclusion criteria (10 listed)
- Have a current or past history of disorder requiring medical treatment within 8 weeks before the first application or infection within 4 weeks before the first application
- Have a disorder within 4 weeks before the first application which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological or cardiovascular system, or congenital metabolic abnormality
- Have a history of gastrointestinal surgery (e.g., liver, kidney, digestive tract) which affects the pharmacokinetics of study drug,
- Have a history of treatment-requiring drug or food allergy or seasonal allergy at screening
- Had caffeine-containing food or drink or alcohol within 72 hours before study drug application in Period I
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 |
|---|---|---|
| E2022 Tape FormulationAlso: DonepezilE2022 tape formulation applied to different application sites and at different intervals in Japanese healthy elderly males | Drug | E2022 Tape Formulation |
Primary outcome
Number and frequency of adverse events
Time frame: 168 hours after the end of application
4 secondary outcomes
Maximal Drug Concentration (CMax)
Time frame: 216 hours after the end of application
Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: 216 hours after the end of application
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 216 hours after the end of application
Plasma Decay Half-Life (t1/2)
Time frame: 216 hours after the end of application
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 Jun 2023.
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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
Eisai Co., Ltd.
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 Tape Formulation in people with Healthy Elderly Male, 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 10 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 Jun 2023. 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 and frequency of adverse events (time frame: 168 hours after the end of application). 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 Jun 2023.