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Trial record 5 of 331 for:    DONEPEZIL

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

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ClinicalTrials.gov Identifier: NCT03438604
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Corium International Inc.

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Donepezil TDS Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 13, 2018
Actual Primary Completion Date : June 19, 2018
Actual Study Completion Date : June 30, 2018


Arm Intervention/treatment
Donepezil TDS with Heat Applied
Corplex Donepezil TDS 5 mg/day with heat applied
Drug: Donepezil TDS
Donepezil Hydrochloride Transdermal Delivery System

Donepezil TDS without Heat
Corplex Donepezil TDS 5 mg/day with no heat applied
Drug: Donepezil TDS
Donepezil Hydrochloride Transdermal Delivery System

Donepezil TDS Extension Study with Heat
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
Donepezil Hydrochloride Transdermal Delivery System




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438604


Locations
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United States, Arizona
Celerion
Phoenix, Arizona, United States, 85283
Sponsors and Collaborators
Corium International Inc.
Investigators
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Principal Investigator: Danielle Armas, MD Celerion

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Responsible Party: Corium International Inc.
ClinicalTrials.gov Identifier: NCT03438604     History of Changes
Other Study ID Numbers: P-16039
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Donepezil
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents