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NCT Number: NCT03438604

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

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Phoenix, Arizona, 85283, United States

About this study

2-Way Crossover study

Approximately 24 healthy, adult male and female subjects will be enrolled.

Subjects will be randomized to 1 of 2 treatment sequences prior to the first TDS application in treatment period 1.

For each treatment period, subjects will have one 7-day TDS applied on their back. Depending on which sequence a subject is randomized to, the healthy subject will either be exposed to heat or not during the TDS wear time.

Blood samples for Donepezil PK will be collected pre-dose until the end of each treatment period.

Adhesion will be monitored throughout the TDS wear time, and skin irritation will be monitored after TDS removal.

Subjects who complete the 2-way crossover study may be eligible to participate in the optional Study Extension Period. In the Study Extension Period, subjects will have their skin surface temperature monitored under the patch and adjacent to the TDS.

Blood samples for Donepezil PK will not be collected, and adhesion will not be monitored for the Study Extension TDS wear period.

Safety will be monitored throughout the study by adverse event reporting and repeated clinical and laboratory evaluations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Donepezil TDS

Drug

Donepezil Hydrochloride Transdermal Delivery System

Primary outcomes

  1. Pharmacokinetics, Cmax

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

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

  2. Pharmacokinetics, AUC

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

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

Secondary outcomes

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

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

    General safety (adverse events and serious adverse events as reported by subject following guidance CTCAE v4.0)

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

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

    Skin irritation score is determined by the sum of Dermal Response score (8-point categorical scale; where 0=no evidence of irritation to 7=strong reaction) using numeric values and Other Effects score (6-point categorical scale where 0=none observed to H=scabs/erosion) using alphabet letters equivalent to numeric values and summarized by the presence and absence of heat

  3. Application Site Mean Adhesion Scores of Donepezil TDS

    Time frame: Daily during 1 week treatment period

    Adhesion data will be collected during each 7-day patch wear period

Sponsors and collaborators

Lead sponsor

Corium, Inc.

Industry

Registry information

Official study title

A Phase 1, 2-Way Crossover Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil 5 mg Transdermal Delivery System (TDS) in Healthy Volunteers

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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