None listed
Conditions
Brief summary
This is a single-site, phase 1, randomized bioavailability study to assess a patch delivery system with and without crystals to be used in Alzheimer's type dementia. The study will enroll 48 healthy volunteers with approximately equal distribution of male and female volunteers. The total study duration is 133 days and includes a 42-day screening window and 2 treatment periods of 36 days each. There will be a washout period between Period 1 and Period 2. In the first treatment period, each participant will receive a single application of once weekly Corplex Donepezil TDS (with or without crystals), applied to either the left or right side of the back according to his or her randomization. After the washout period, the participant will have the other Corplex Donepezil TDS type applied on the opposite side of the back during Treatment Period 2.
Interventions
This is a randomized, blinded, 2-way crossover study of a once-weekly 10mg/day Corplex® Donepezil Transdermal Delivery Systems (TDS). This study will evaluate if there are any differences in absorption of Donepezil in a TDS containing crystals (covering >0.1 and <1%) and TDS with no crystals.
All eligible participants will be randomized to 1 of 4 treatment sequences as described below:
Period 1 Period 2
Treatment Sequence 1 TDS A: Left Back TDS
This is a randomized, blinded, 2-way crossover study of a once-weekly 10mg/day Corplex® Donepezil Transdermal Delivery Systems (TDS). This study will evaluate if there are any differences in absorption of Donepezil in a TDS containing crystals (covering >0.1 and <1%) and TDS with no crystals. All eligible participants will be randomized to 1 of 4 treatment sequences as described below: Period 1 Period 2 Treatment Sequence 1 TDS A: Left Back TDS B: Right Back Treatment Sequence 2 TDS B: Left Back TDS A: Right Back Treatment Sequence 3 TDS A: Right Back TDS B: Left Back Treatment Sequence 4 TDS B: Right Back TDS A: Left Back TDA A= with crystals; TDS B=without crystals Each participant will participate in 2 periods. In the first period, the participant will receive a single TDS (A or B) placed on the mid-lower back by clinical staff (such as nurses). The TDS will be worn for 7 days. After a washout period of 49 days, the participant will have the other TDS type applied to the opposite mid-lower back for 7 days (1 week) during Treatment Period 2 and will then be followed for 28 days after TDS removal. 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) and 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 methods 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 level, or have official documentation of at least 1 of the sterilization procedure no less than 6 months prior to Screening. 7. For a male: must agree to an acceptable birth control methods from Screening until after the End of Study Visit
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. Has intolerance to venipuncture and/or inability to comply with the extensive blood sampling required for this study or does not have suitably intact veins in both arms. 6. Potential for occupational exposure to anticholinesterase agents in the 5 weeks prior to Screening through the last TDS removal. 7. Female subjects with a positive pregnancy test or who are lactating 8. 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. 9. 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. 10. 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 11. History of or current consumption of high levels of caffeine (equivalent to 3 regular cups of coffee or 2 energy drinks, per day). 12. 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