None listed
Conditions
Brief summary
This is a single-site phase 1, randomized, crossover study to assess the effects of 4 different bond strengths on the performance of a patch delivery system to be used in Alzheimer's type dementia. The study will enroll 36 participants. The total study duration is 98 days which includes a 42-day screening window, 4 consecutive treatment periods, and 3 follow-up visits over 28 days.
Interventions
This is a randomized, 4-way crossover study to evaluate the effects of 4 different bonding strengths on the wear performance of a once-weekly 10mg/day Corplex Donepezil Transdermal Delivery (TDS).
The 4 different bonding strengths are:
1. Control (TDS B) - The current strength that is used in previous clinical studies and will serve as the control strength (TDS B) in this study
2. Low (TDS C) - Approximately 12% greater in bonding strength than the control
3. Medium (TDS D) - Approximately 25%
This is a randomized, 4-way crossover study to evaluate the effects of 4 different bonding strengths on the wear performance of a once-weekly 10mg/day Corplex Donepezil Transdermal Delivery (TDS). The 4 different bonding strengths are: 1. Control (TDS B) - The current strength that is used in previous clinical studies and will serve as the control strength (TDS B) in this study 2. Low (TDS C) - Approximately 12% greater in bonding strength than the control 3. Medium (TDS D) - Approximately 25% greater in bonding strength than the control 4. High (TDS E) - Approximately 37% greater in bonding strength than the control Eligible participants will receive all 4 types of TDS (B, C, D, and E) in a randomized order in 4 consecutive treatment periods. In each treatment period, the participant will wear a single TDS placed on the back by clinic staff (including nurses) and worn for 7 days. On the day the TDS patch is removed, another TDS patch of different strength will be placed. Safety laboratory tests, physical examinations, vital signs, ECGs, adhesion assessments, and skin irritation assessments will be performed to monitor safety and compliance.
Sponsors
Corium Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key inclusion criteria include: 1. Healthy, adult, male or female, at least 18 years of age at Screening, 2. Nonsmoker or occasional smoker (less than or equal to 1 cigarette or equivalent/day) must agree not to smoke or agree to consume no more than 1 cigarette or equivalent/day from the Screening Visit until after the End of Study Visit. 3. Body mass index between 18.0 and 32.0 kg/m2 at Screening. 4. Sparse, minimal, and fine hair on skin at application sites 5. If a female of childbearing potential: must be either sexually inactive (abstinent) for at least 14 days prior to the first TDS application and remain sexually inactive throughout the study or be using an acceptable birth control method while within the study. 6. A female of nonchildbearing potential: defined as either postmenopausal with amenorrhea for at least 1 year prior to Screening AND have an acceptable follicle-stimulating hormone serum levels or have official documentation of at least 1 sterilization procedures no less than 6 months prior to Screening. 7. For a male: must agree to use an acceptable birth control method from Screening AND for at least 90 days following the last TDS removal
Exclusion criteria
Key exclusion criteria include: 1. History of any clinically significant medical or psychiatric condition or disease that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study 2. History of alcoholism or drug abuse within the past 2 years prior to the first study product treatment, or current alcohol or drug abuse 3. History of significant multiple, severe contact allergies, or has had 1 or more anaphylactic reactions, or is significantly intolerant to prescription or nonprescription drugs. 4. Exhibiting symptoms suggestive of bladder outflow obstruction as assessed by the investigator. 5. Potential for occupational exposure to anticholinesterase agents in the 5 weeks prior to Screening through the last TDS removal. 6. Female subjects with a positive pregnancy test or who are lactating. 7. History or presence of hairy skin on application sites that may potentially interfere with TDS adhesion and drug absorption. Clipping is permitted to remove fine or sparse hair. Subjects with heavy hair growth at the application site will not be eligible even with clipping. 8. History or presence of significant skin damage, diffuse skin diseases, scars, tattoos on the application sites, or other skin disturbances or coloration that would interfere with placement of test articles, skin assessment, or reactions to drug as deemed by the investigator to potentially interfere with drug absorption or irritation assessments; subjects with a spray tan applied less than 30 days prior to study dose are excluded. 9. History or presence of significant dermatological disease or condition, such as atopy, psoriasis, vitiligo or conditions that are known to alter the skin appearance or physiologic response. 10. History of or current consumption of high levels of caffeine (equivalent to 3 regular cups of coffee or 2 energy drinks, per day). 11. Donation of blood or significant blood loss within 56 days prior to the first study product treatment. 13. Plasma donation within 7 days prior to the first study product treatment. 14. Use of donepezil HCl or related drugs within 60 days prior to the first study product treatment. 15. Clinically significant depression symptoms or suicidal ideation or behavior.
Outcome results
None listed