A Study of E2022 Tape Formulation (Overlay-integrated E2022 18 mg Tape Formulation) for Different Application Sites and Intervals in Japanese Healthy Elderly Males

NCT02225288 | Completed Phase 1

• 1 other identifier: E2022-J081-007
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, 4-group, open-label study in Japanese healthy elderly males. A total of 48 subjects will be randomized to one of four groups (A to D, 12 subjects/group) to administer one E2022 tape to designated sites.

Conditions

Healthy Subjects

Keywords

Healthy Subjects; Japanese; Males

Outcome Measures

Primary Outcomes (1)

• Number and frequency of adverse events

  168 hours after the end of application

Secondary Outcomes (4)

• Pharmacokinetics of E2022: Cmax

  216 hours after the end of application

• Pharmacokinetics of E2022: AUC

  216 hours after the end of application

• Pharmacokinetics of E2022: Tmax

  216 hours after the end of application

• Pharmacokinetics of E2022: t1/2

  216 hours after the end of application

Study Arms (4)

Group A

EXPERIMENTAL

Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group A: 48 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications \[applying in the morning and removing next morning\])

Drug: E2022

Group B

EXPERIMENTAL

Period 1: Apply one E2022 tape to the designated site (back or upper arm) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or upper arm, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group B: 72 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications \[applying in the morning and removing next morning\])

Drug: E2022

Group C

EXPERIMENTAL

Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group C: 96 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications \[applying in the morning and removing next morning\])

Drug: E2022

Group D

EXPERIMENTAL

Period 1: Apply one E2022 tape to the designated site (back or chest) for 24 hours (applying in the morning and removing next morning) Period 2: Apply one E2022 tape to the designated site (back or chest, but different from Period 1) for 24 hours (applying in the morning and removing next morning) Period 3: Apply one E2022 tape to back (contralateral to Period 1 and 2). After the specified intervals (Group D: 120 hours), apply a new E2022 tape to the same site (for 24 hours after the first and second applications \[applying in the morning and removing next morning\])

Drug: E2022

Interventions

E2022 DRUG

transdermal E2022 tape formulation (8.1 cm x 8.1 cm)

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 1
• 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 week before Period 1
• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kagoshima, Kagoshima-ken, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 26, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: April 2, 2015

Record last verified: 2015-03

Locations

JP (1)