A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations
Completed · Phase 1
Conditions studied: Alzheimer's Disease
In brief
A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations
Key facts
- Study ID
- NCT03432195
- Run by
- Corium, Inc.
- People needed
- 66
- Starts
- 2018-01-31
- Expected to finish
- 2018-06-28
- Last updated by the study team
- 2018-08-07
Who can join
Age: 30 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 Criteria:
- 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
Where it is running
- Celerion — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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