A study to evaluate the safety and tolerability of multiple formulations of an investigational transdermal patch in healthy volunteers

Phase 1

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

• Registration Number: ACTRN12619000574145
• Lead Sponsor: INC Research Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Healthy, adult, Caucasian females and males aged 50 to 85 years (inclusive) on the day of randomization. Enrollment will aim for 100 percent females; however, up to 25 percent males may be enrolled per the Sponsor’s approval and a minimum of 5 subjects (3-4 females, and 1-2 males if applicable) who are between the ages of 70 and 85 years.
2. Has a body mass index (BMI) between 18-32 kg/m^2 (inclusive).
3. Have a Fitzpatrick skin type of I, II, or III
4. Must be willing and able to understand and comply with the scheduled study visits, treatment plans, laboratory tests, and other procedures by providing a signed and dated written informed consent prior to the initiation of any study procedures.
5. Women of child-bearing potential and men should be sexually inactive (abstinent). Abstinence, defined as complete avoidance of heterosexual intercourse, is an acceptable form of contraception. .
6. Willing and able to discontinue all nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) NSAID analgesic therapy, 30 days prior to Day 1 and until completion of the Study Exit Visit.
7. If the subject is receiving allowed medications for the treatment of non-excluded medical conditions, the dose must be stable for at least 28 days before randomization on Day 1.

Exclusion Criteria

1. Participation in another clinical study with an IP or device within 30 days or 5 half-lives, whichever is longer, prior to screening.
2. Plasma donation within 28 days of screening or any blood donation or blood loss greater than 500 mL within 3 months of screening.
3. Has skin color that may not allow reliable evaluation of irritation.
4. Female subjects with a positive pregnancy test or lactating.
5. Has intolerance to venipuncture and/or inability to comply with the blood sampling required for this study.
6. Has cuts, scratches/abrasions, scars, breaks in the skin surface, skin with excessive hair, indications of sunburn, excessive skin tanning, stretch marks at the application site, recent tattoos (within the last 6 months) or has any abnormalities at the intended application sites which would affect absorption of the IP.
7. Unwilling to refrain from using tanning salons, saunas, or from sunbathing during the course of the study. Unwilling to avoid shaving of the application site, waxing of the application site, or using lotion hair remover on or near application site from 48 hours before patch application and during the conduct of the study.
8. Has a history of or is currently consuming high caffeine levels
9. Smokes more than 20 cigarettes per day for more than 10 years
10. Presence of any major psychiatric disorder
11. Significant cardiovascular disease
12. Significant or chronic lung disease
13. Diabetes complicated
14. Known or suspected systemic infection
15. History of severe allergy/hypersensitivity reactions
16. History of cancer
17. Transient ischemic attack or stroke in the last 3 years.
18. History of suspected alcohol or drug dependence
19. Myocardial infarction, hospitalization for unstable angina or arrhythmia or unexplained syncope
20. Clinically important infection, including chronic, persistent or acute infection, within 3 months of screening or between screening and randomization.
21. Any medical or surgical procedure or trauma within 28 days of Day 1.
22. Current serious or unstable clinically important illness,
23. Exhibiting symptoms suggestive of bladder outflow obstruction
24. Has a history of allergic reactions to medical grade adhesive tapes, sunscreens, cosmetics, lotions, fragrances, or latex.
25. Use of adjuvant analgesics
26. Use of muscle relaxants
27. Use of any topical medication in the areas intended for patch application within 14 days prior to the first patch application and throughout the study.
28. Use of any topical products without medicinal ingredient (including but not limited to perfumes, body lotions, sunscreens, spray or patch oils, creams and alcohol) on the area intended for patch application within 48 hours prior to the first patch application
29. Prior or current use of memantine hydrochloride, or to piperidine derivatives and related drugs.
30. Clinically important abnormality in physical examination, vital signs or clinical laboratory test.
31. Clinically significant hypertension
32. Any clinically significant abnormality in ECG rhythm, conduction or morphology
33. A positive pregnancy test at screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified