An interventional study to evaluate the effects of formulation on the Pharmacokinetics (PK, the measure of how the human body processes a substance) and adhesion (how well the patch sticks to the skin) of two Donepezil Transdermal Delivery System (TDS, a patch that delivers a drug) formulations, worn for seven days, applied to the backs of healthy participants.

Phase 1

Completed

• Conditions: Alzheimer's Disease; Neurological - Alzheimer's disease

• Registration Number: ACTRN12616000836437
• Lead Sponsor: INCResearch Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in the TDS Main Study and Oral Sub-Study.
1. Caucasian male or female aged 50 to 80 years (inclusive) on Day 1.
2. Has a Body Mass Index between 18-32 kg/m2 (inclusive) as calculated using the site standard procedures.
3. Must be willing and able to understand and participate in all scheduled evaluations by providing a signed and dated written informed consent prior to the initiation of any study procedures.
4. Women and men of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Postmenopausal status will be verified by the absence of the menstrual cycle for twelve consecutive months or medical documentation of an oophorectomy or hysterectomy or bilateral tubal ligation and follicle-stimulating hormone (FSH) blood test at screening (FSH must be > 25.8 mIU/mL). Subjects on stable doses of hormone replacement therapy who have an FSH level < 25.8 mIU/mL can be enrolled at the Investigator's discretion.
5. If the subject is receiving allowed medications for the treatment of non-excluded medical conditions, the dose must be stable for at least 14 days or 5 half-lives (whichever is longer) before Day 1. Permitted medications must be consistent with the current label for oral donepezil (Aricept 'Registered Trademark') tablets.

Exclusion Criteria

Participants who meet any of the following exclusion criteria will be excluded from participation in the TDS Main Study.
Participants who meet any of the following exclusion criteria that are applicable to the Oral Sub-study will be excluded from participation in the sub-study.

1. Dosing with an Investigational Product not containing donepezil within 60 days prior to screening.
2. Plasma donation within 28 days of screening or any blood donation or blood loss greater than 500 mL within three months of screening.
3. Has skin color or tone that may not allow reliable evaluation of irritation. (Applicable to the TDS Main Study only)
4. Unwilling to abstain from new strenuous physical exercise and from alcohol consumption for 48 hours prior to scheduled PK blood draws at the clinic visits (subjects can maintain their normal exercise routine).
5. Has intolerance to venipuncture and/or inability to comply with the extensive blood sampling required for this study or does not have suitable veins in both arms.
6. Has cuts, scratches/abrasions, scars, breaks in the skin surface, recent tattoos (within last six months) at the TDS application site, skin with excessive hair, indications of sunburn, excessive skin tanning, stretch marks and/or similar abnormalities at the intended TDS application sites which would affect absorption of donepezil. (Applicable to the TDS Main Study only).
7. Unwilling to avoid using tanning salons, saunas, or sun bathing during the conduct of the study. Unwilling to avoid shaving of the TDS application site, waxing of the TDS application site, or use of lotion hair remover on or near the TDS application site from 48 hours before patch application and during the conduct of the study. (Applicable to the TDS Main Study only).
8. Unwilling to abstain from food or beverages containing grapefruit, starfruit, pomegranate, limes, seville oranges, pomelo and food or beverages containing greater than 5% of the aforementioned fruits (examples are: fruit drinks, fruit punches, fruit cocktails, fruit aides) 14 days prior to the first dose and throughout the study.
9. Subjects with a history of or who are currently consuming high caffeine levels (greater than ten regular or espresso cups of coffee per day); heavy smokers who smoke more than 20 cigarettes per day. Exception will be made for lighter smokers and subjects on stable doses of nicotine patches.
10. Presence of any major psychiatric disorder if, in the opinion of the Investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect/tolerability, or affect the subject’s ability to complete the study.
11. Significant cardiovascular disease, including moderate or severe congestive heart failure (ejection fraction of less than 40%) or clinically significant stenosis or occlusion of a carotid or vertebral artery.
12. Significant or chronic lung disease, including Chronic Obstructive Pulmonary Disease and severe or unstable asthma.
13. Diabetes complicated with retinopathy (by history), neuropathy (by history or physical examination), or nephropathy (by history). Uncomplicated, stable diabetes that is well controlled and actively managed is not exclusionary.
14. Known or suspected systemic infection, including human immunodeficiency virus, hepatitis B virus or hepatitis C virus, or tuberculosis or qualitative syphilis test as judged by the Investigator at screening.
15. History of severe allergy/hypersensitivity reactions or on

Study & Design

• Study Type: Interventional
• Study Design: Not specified