E2022 Patch Formulation Multiple Dose Study

NCT01450839 | Completed Phase 1

• 1 other identifier: E2022-J081-002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety and tolerability of a E2022 16 mg tape when applied repeatedly for 17 days to healthy elderly Japanese male subjects, using E2022 placebo tape as the control.

Conditions

Healthy

Keywords

Transdermal Administration; Japanese; elderly; male; volunteers

Outcome Measures

Primary Outcomes (1)

• Composite (or Profile) of Pharmacokinetics

  Cmax, Area Under Curve, Tmax

  predose, 0,1, 2, 3, 4, 6, 8,1 2, 24, 48, 72, 96 hours post-dose

Study Arms (2)

E2020 5 mg tablet and tape

EXPERIMENTAL

Drug: E2022

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

E2022 DRUG

The treatment period consists of 2 periods, Period I and Period II. In Period I, one 5 mg E2020 tablet will be administered in a single dose. In Period II, the tape containing 16 mg E2022 (which corresponds to one 5 mg E2020 tablet) will be applied repeatedly for 17 days. A washout period of at least 8 days will be allowed between the day of single dose administration in Period I and the first day of repeated application in Period II. A post-treatment examination will be performed at least 21 days after the last removal of the investigational product in Period II.

E2020 5 mg tablet and tape

Placebo DRUG

Matching Placebo tablets and tape

2

Eligibility Criteria

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

You may qualify if:

• Subjects who are non-smoking males (not smoking for at least 4 weeks before the administration of the investigational product in Period I) 65 years or older at the time of giving informed consent
• Subjects whose body mass index (BMI) is 18.5 kg/m\^2 to less than 28.0 kg/m\^2 at the screening
• Subjects who give voluntary written consent to participate in the study
• Subjects who have been fully informed of matters subjects are required to observe during the study and can, and are willing to, comply with the rules.

You may not qualify if:

• Subjects with a history of treatment-requiring disease within 8 weeks before administration of the investigational product in Period I or history of infection within 4 weeks before administration of the investigational product in Period I
• Subjects who have, within 4 weeks before administration of the investigational product in Period I, a disease that might affect the evaluation of the investigational product, such as mental, gastrointestinal, hepatic, renal, respiratory, endocrine, hematological, nervous, or cardiovascular diseases, and inborn error of metabolism
• Subjects with a history of surgical treatment of the gastrointestinal tract (e.g., resection of the liver, kidney, gastrointestinal tract, etc.) that may affect the pharmacokinetics of the investigational product
• Subjects with a history of treatment-requiring drug or food allergy or with seasonal allergy at the screening
• Subjects with a change in body weight of more than 10% at 1 day before investigational product administration in Period I, compared with that observed at the screening
• Subjects with clinically significant, treatment-requiring symptoms or impairment of organ function, judging from the subjective symptoms/objective findings, vital signs, 12-lead ECG, or laboratory test performed during the period from the screening to immediately before investigational product administration in Period I
• Subjects with QTc\>450 ms on 12-lead ECG performed at the screening or immediately before investigational product administration in Period I
• Subjects who are positive for human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBs antigen), hepatitis C virus (HCV) antibody, or qualitative syphilis test, at the screening
• Subjects with a history of, or suspected diagnosis of, drug or alcohol dependence or Subjects who are positive for urine drug test at the screening or 1 day before investigational product administration in Period I
• Subjects who took caffeine-containing or alcoholic beverage within 72 hours before investigational product administration in Period I
• Subjects who took, within 2 weeks before investigational product administration in Period I, nutritional supplements, herb-containing drug preparations (including Chinese medicines) or other foods or beverages (e.g., grapefruit-containing foods or beverages) that may affect drug-metabolizing enzymes or transporters
• Subjects who took drug preparations containing St. John's wort within 4 weeks before investigational product administration in Period I
• Subjects who took prescription drugs within 4 weeks before investigational product administration in Period I
• Subjects who took non-prescription drugs within 2 weeks before investigational product administration in Period I
• Subjects who participated in another clinical study within 16 weeks before investigational product administration in Period I and used an investigational product or medical device

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kagoshima, Kagoshima-ken, Japan

Location

Study Officials

• Hidetaka Hiramatsu

  Neuroscience Cliical Development Section, Japan /Asia Clinical Research PCU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 12, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

JP (1)