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CompletedNCT02042729Updated Feb 21, 2014

A Phase 1 Comparative Study of E2022 Current and New Patch Formulations

A Phase 1 interventional study of E2022- Current Formula Tape and E2022- New Formula Tape in Healthy, sponsored by Eisai Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-21.

Sponsored by Eisai Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
20 Years to 39 Years
Sex
Male
01

Study summary

The purpose of this study is to investigate the safety and pharmacokinetics of new patch formulation (tape) of E2022 by conducting patch test.

02

Conditions studied

  • Healthy

Keywords

  • volunteer
03

In context

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 149 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Non-smoker or not smoking for 4 weeks or longer before study treatment
  2. BMI at screening is greater than or equal to 18.5 kg/m2 or less than 25.0 kg/m2
  3. With written informed consent
  4. Given full explanation of this study and is willing to and able to comply with study requirements.

Exclusion criteria

Exclusion criteria

(Cohort 1 and 2):

  1. Have a disorder which affects the evaluation of study drug such as psychiatric, gastrointestinal, hepatic, renal, respiratory, endocrinological, hematological, neurological, or cardiovascular system, or congenital metabolic abnormality
  2. Have a clinically significant abnormality or organ dysfunction
  3. Have a history of allergy to drug or food requiring medical treatment or seasonal allergy at screening
  4. Have a history or complication of contact dermatitis or atopic dermatitis
  5. Have hairy back or have shaved within 4 weeks before study treatment
  6. Have a skin disease (e.g., eczema, dermatitis, dyschromatosis), or skin damage (e.g., injury, scar, or sun burn) which may affect skin assessment
  7. Have a history or suspected to have drug or alcohol dependence, or positive for urine drug screen at baseline or a day before screening
  8. Have had caffeine-containing drink or food, or alcohol within 72 hours before study treatment
  9. Have used liquid product (including cosmetics), or applied patch, tape, or bandage on the back within 4 weeks before study treatment
  10. Had hard exercise at least 5 days a week or a 1-hour or longer hard exercise within 2 weeks before study treatment

(Only Cohort 2):

  1. Meet QTc of greater than 450 milliseconds at screening or immediately before study treatment
  2. Had nutrients, herb preparations (e.g. oriental medicine), other food or drink (e.g., grapefruit-containing juice) which may affect the activity of drug-metabolizing enzyme or transporter within 2 weeks before study treatment
  3. Had St. John's Wort-containing preparation within 4 weeks before Period 1 application
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    E2022- Tape Formulation

    Drug: E2022- Current Formula Tape

  • Placebo comparator
    Matching Placebo E2022

    Matching Placebo

    Drug: E2022 Matching Placebo- Current Formula Tape

  • Active comparator
    E2022- New Formulation

    Drug: E2022- New Formula Tape

  • Placebo comparator
    Placebo E2022- New Formulation

    Matching Placebo

    Drug: E2022 Matching Placebo- New Formula Tape

Interventions

  • DrugE2022- Current Formula Tape

    Cohort I: E2022 current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test. Cohort II: E2022 current formula tape administered to skin application site and evaluated for 20 days.

  • DrugE2022- New Formula Tape

    Cohort I: E2022 new formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test. Cohort II: E2022 new formula tape administered to skin application site and evaluated for 20 days.

  • DrugE2022 Matching Placebo- Current Formula Tape

    Also known as: Cohort I: E2022 Matching Placebo current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.

  • DrugE2022 Matching Placebo- New Formula Tape

    Also known as: Cohort I: E2022 Matching Placebo new formula tape administered on a skin application site and evaluated for

06

What researchers measure

Primary outcomes

  1. Number of Adverse Events

    Time frame: 10 days (Cohort I) and 40 days (Cohort II)

  2. Frequency of Adverse Events

    Time frame: 10 days (Cohort I) and 40 days (Cohort II)

Secondary outcomes

  1. Pharmacokinetic Parameter: Cmax

    Time frame: 40 days (Cohort II)

  2. Pharmacokinetic Parameter: Tmax

    Time frame: 40 days (Cohort II)

  3. Pharmacokinetic Parameter: AUC

    Time frame: 40 days (Cohort II)

07

Study locations

1 site
  • Fukuoka, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02042729
Lead sponsor
Eisai Co., Ltd.
Responsible party
Sponsor
First posted
Jan 23, 2014
Start date
Aug 2012
Primary completion
Oct 2012
Completion
Dec 2012
Last update
Feb 21, 2014

Study contacts

Hidetaka Hiramatsu
study director · Eisai Co., Ltd.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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