A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept®
Completed · Phase 1
Conditions studied: Alzheimer Disease
In brief
A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy Adult Subjects
Key facts
- Study ID
- NCT02968719
- Run by
- Corium, Inc.
- People needed
- 107
- Starts
- 2016-11-01
- Expected to finish
- 2017-07-11
- Last updated by the study team
- 2018-08-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy, adult, Caucasian, male or female ≥18 years of age at screening
- 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.
- Female subjects with a positive pregnancy test or lactating
- Positive urine drug or alcohol results
- 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
- Any of the following drugs for 28 days prior to the first dose of study drug in Treatment Period 1 and throughout the study:
- significant inducers of cytochrome P450 (CYP) enzymes and/or P-glycoprotein
- anti-inflammatory drugs or cyclooxygenase 2 (COX-2) analgesic
- beta-blockers;
- anti-fungal medications;
- anti-histamines;
- cholinergics and anti-cholinergics;
- oral corticosteroids;
- Prolia;
- Adjuvant analgesics
- Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug
- History or presence of excessive hairy skin on application sites as deemed by the Investigator to potentially interfere with drug absorption
- History or presence of significant skin damage, diffuse skin diseases, scars, tattoos on the application sites or other skin disturbances as deemed by the Investigator to potentially interfere with drug absorption or irritation assessments
Where it is running
- Celerion — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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