Completed

A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals

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What is being tested

E2022 Tape Formulation

Drug
Who is being recruted

Over 65 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2012
See protocol details

Summary

Principal SponsorEisai Co., Ltd.
Last updated: June 18, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2012

Actual date on which the first participant was enrolled.

A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and pharmacokinetics.

NCT01843556
Principal SponsorEisai Co., Ltd.
Last updated: June 18, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2
Given full explanation of this study and is willing to and able to comply with the protocol requirements
Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older at informed consent
Written informed consent
10 exclusion criteria prevent from participating
Eczema, dermatitis, abnormal pigmentation, injury, or scar at application sites which may affect the evaluation of skin symptoms
Excessively hairy or have shaved at application sites (back, upper limb, chest) within 4 weeks before Period 1
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Kagoshima, JapanOpen in Google Maps
CompletedOne Study Center