A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations

• Status: Completed
• Trial end date: 2018-06-28
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Corium International Inc.; Corium, Inc.
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• 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