A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals in Japanese Healthy Elderly Males

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.

Study Overview

• Status: Completed
• Conditions: Healthy Elderly Male
• Intervention / Treatment: Drug: E2022 Tape Formulation

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kagoshima, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Male non-smokers (not smoking at least 4 weeks before Period 1) aged 65 years or older at informed consent
2. BMI at screening is 18.5 kg/m2 or above - below 28.0 kg/m2
3. Written informed consent
4. Given full explanation of this study and is willing to and able to comply with the protocol requirements

Exclusion criteria:

1. 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
2. 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
3. Have a history of gastrointestinal surgery (e.g., liver, kidney, digestive tract) which affects the pharmacokinetics of study drug,
4. Have a history of treatment-requiring drug or food allergy or seasonal allergy at screening
5. Had caffeine-containing food or drink or alcohol within 72 hours before study drug application in Period I
6. 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
7. Have used liquid products (including cosmetics) on study application sites (back, upper limb, chest), patch, tape or bandage, within 4 weeks before Period 1
8. Present or past clinical signs of skin hypersensitivity to topical product or atopic dermatitis
9. Excessively hairy or have shaved at application sites (back, upper limb, chest) within 4 weeks before Period 1
10. Eczema, dermatitis, abnormal pigmentation, injury, or scar at application sites which may affect the evaluation of skin symptoms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E2022 Tape Formulation	Drug: E2022 Tape Formulation; E2022 tape formulation applied to different application sites and at different intervals in Japanese healthy elderly males; Other Names: Donepezil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number and frequency of adverse events	168 hours after the end of application

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximal Drug Concentration (CMax)	216 hours after the end of application
Area Under the Plasma Concentration-Time Curve (AUC)	216 hours after the end of application
Time to Reach Maximum Observed Plasma Concentration (Tmax)	216 hours after the end of application
Plasma Decay Half-Life (t1/2)	216 hours after the end of application

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Study Director: Hidetaka Hiramatsu, Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 25, 2013
• First Submitted That Met QC Criteria: April 29, 2013
• First Posted (Estimated): April 30, 2013

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: E2022-J081-003