A Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil Transdermal Delivery System (TDS)

NCT03438604 | Completed Phase 1 FDA Drug

• 1 other identifier: P-16039
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A study to assess the effect of heat application on the delivery profile of Corplex™ Donepezil Transdermal Delivery System (TDS)

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics, Cmax

  Peak plasma concentration (Cmax) of once-weekly Donepezil TDS in the presence and absence of heat

  Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total

• Pharmacokinetics, AUC

  Area under the curve (AUC) of once-weekly Donepezil TDS in the presence and absence of heat

  Blood samples for the Donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Daily during 1 week treatment period and during the 5 week follow-on period

• Summary Listing of Skin Irritation Score of Donepezil TDS by post-removal time point

  0.5 hr, 24 hr, 48 hr, 72 hr after each TDS removal (3 days)

• Application Site Mean Adhesion Scores of Donepezil TDS

  Daily during 1 week treatment period

Study Arms (3)

Donepezil TDS with Heat Applied

OTHER

Corplex Donepezil TDS 5 mg/day with heat applied

Drug: Donepezil TDS

Donepezil TDS without Heat

OTHER

Corplex Donepezil TDS 5 mg/day with no heat applied

Drug: Donepezil TDS

Donepezil TDS Extension Study with Heat

OTHER

Corplex Donepezil TDS 5 mg/day with heat. Two skin sensors will be placed underneath the TDS and adjacent to the TDS.

Drug: Donepezil TDS

Interventions

Donepezil TDS DRUG

Donepezil Hydrochloride Transdermal Delivery System

Donepezil TDS Extension Study with Heat; Donepezil TDS with Heat Applied; Donepezil TDS without Heat

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, adult, male or female ≥ 30 years of age

You may not qualify if:

• History of any illness 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
• History or presence of alcoholism or drug abuse within the past 2 years prior to the first study product treatment
• History or presence of hypersensitivity or idiosyncratic reaction to the study products or related compounds
• History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs
• History or presence of excessive sweating
• History or presence of hairy skin on application sites
• History or presence of significant skin damage or disease at application sites
• Any medical or surgical procedure or trauma within 28 days prior to the first study product treatment

Sponsors & Collaborators

• Corium, Inc.: lead

Study Sites (1)

Celerion

Phoenix, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Danielle Armas, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 19, 2018
• Study Start: February 13, 2018
• Primary Completion: June 19, 2018
• Study Completion: June 30, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)