Status:
COMPLETED
A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations
Lead Sponsor:
Corium, Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE1
Brief Summary
A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
Detailed Description
Randomized, open-label, 3-way crossover study Up to 66 healthy, adult male and female subjects will be enrolled. All subjects will receive Corplex Donepezil TDS patches applied to 3 different locati...
Eligibility Criteria
Inclusion
- Healthy, adult, male or female
- Body mass index ≥ 18.0 and ≤ 32.0 kg/m2 at screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator
- Have a Fitzpatrick skin type of I, II or III or have skin colorimeter scores equivalent to the allowed Fitzpatrick skin type
- Key
Exclusion
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (including piperidine derivatives and other cholinesterase inhibitors)
- 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
- Potential for occupational exposure to anticholinesterase agents
- Estimated creatinine clearance in non-elderly subjects \<80 mL/min at screening and in elderly subjects (i.e., ≥55 years of age) \<60 mL/min at screening
- Hemoglobin value of less than 11.5 g/dl for females, 13.0 g/dl for males at screening and first check-in
- Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug
- History or presence of significant skin damage or other skin disturbances as deemed by the Investigator to potentially interfere with patch procedures
- Use of donepezil hydrochloride or related drugs within 60 days prior to the first study drug administration
- Clinically significant depression symptoms or suicidal ideation or behavior as determined by the Investigator
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2018
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03432195
Start Date
January 31 2018
End Date
June 28 2018
Last Update
August 7 2018
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283