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Effect of Heat on Rivastigmine TDS Products

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915626
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Audra Stinchcomb, University of Maryland, Baltimore

Brief Summary:
This research study is designed to measure the amount of medicine in blood over time after the patch is placed on the skin with and without external heat application.

Condition or disease Intervention/treatment Phase
Bioavailability Drug: Rivastigmine (RLD) transdermal patch Drug: Rivastigmine (generic) transdermal patch Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Determination of Serum Rivastigmine Levels After Using Rivastigmine Transdermal Delivery Systems With and Without Standardized Heat Application in Healthy Human Volunteers
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RLD patch
RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours
Drug: Rivastigmine (RLD) transdermal patch
brand name patch
Other Name: brand name patch

Experimental: generic patch
generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours
Drug: Rivastigmine (generic) transdermal patch
generic patch
Other Name: generic patch

Experimental: RLD patch with heat
RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application
Drug: Rivastigmine (RLD) transdermal patch
brand name patch
Other Name: brand name patch

Experimental: generic patch with heat
generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application
Drug: Rivastigmine (generic) transdermal patch
generic patch
Other Name: generic patch




Primary Outcome Measures :
  1. Rivastigmine concentration of collected serum samples [ Time Frame: 0-12 hours for each subject for each of the four study arms (10-12 weeks) ]
    rivastigmine in serum



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men or non-pregnant, non-lactating women who are of any ethnic background between the age of 18 to 45 years old
  2. Subjects must be non-smokers/tobacco users (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products
  3. Provide written informed consent before initiation of any of the study procedures
  4. Agree not to participate in another clinical trial/study or to participate in an investigational drug study for at least one month after the last study session
  5. Able to adhere to the study restrictions and protocol schedule
  6. Able to participate in all study sessions
  7. Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination and medication history
  8. Negative urine drug screening test (cannabinoids, amphetamines, barbiturates, benzodiazepine, cocaine, methadone, opiates, PCP)
  9. Have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine transaminase (ALT) and aspartate aminotransferase (AST)
  10. Have normal screening laboratories for urine protein and urine glucose
  11. Female subjects must be of non-childbearing potential (as defined as surgically sterile [i.e. history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of each procedure day, and must agree to use reliable hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or a vasectomized partner
  12. Agree not to donate blood to a blood bank throughout participation in the study and for at least three months after last procedure day
  13. Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block. (sinus rhythm is between 55-100 beats per minute)
  14. Have normal vital signs:

    • Temperature 35-37.9°C (95-100.3°F)
    • Systolic blood pressure 90-140 mmHg
    • Diastolic blood pressure 60-90 mmHg
    • Heart rate 55-100 beats per minute
    • Respiration rate 12-20 breaths per minute

Exclusion Criteria:

  1. Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of any study session
  2. Smokers/tobacco users (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patch or electronic cigarettes)
  3. Participation in any ongoing investigational drug trial/study or clinical drug trial/study
  4. History of lung, heart, respiratory or blood disease
  5. Active positive Hepatitis B, C and/or HIV serologies
  6. Positive urine drug screening test
  7. Use of chronic prescription medications during the period 0 to 30 days; or over-the-counter medications (e.g. cholinomimetic drugs [used to treat diseases like acid reflux in children, glaucoma, dry mouth associated with Sjögren's Syndrome], anticholinergics [used to treat diseases like asthma, incontinence, gastrointestinal cramps, and muscular spasms], antihistamines, topical corticosteroids) and short term (<30 days) prescription medications during the period 0-3 days before a study session vitamin, herbal supplements and birth control medications not included)
  8. Donation or loss of greater than one pint of blood within 60 days of entry to the study
  9. Any prior allergies to rivastigmine, other carbamate derivatives, other ingredients in the patch, to medical tape products or other skin patches
  10. Subject has problems with urinary retention, gastric retention or gastrointestinal obstruction
  11. Subject has continuous spasms, muscle contractions, motor restlessness, rigidity, slowness of movement, tremors or irregular jerky movements
  12. Subject has ulcers or gastrointestinal bleeding
  13. Subject has asthma or blocked airflow making it hard to breathe (COPD)
  14. Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within one month before enrollment in this study or expects to receive an experimental agent during the study
  15. Any condition that would, in the opinion of the Medically Accountable Investigator (MAI), place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
  16. Consumption (food or drink) of alcohol within 24 h prior to dose administration
  17. History as either reported by the subject or evident to the investigator of infectious disease or skin infection or of chronic skin disease (e.g., psoriasis, atopic dermatitis)
  18. History of diabetes
  19. Hereditary skin disorders or any skin inflammatory conditions as reported by the subject or evident to the MAI
  20. History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and did not involve the investigative sites
  21. Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at the application site (upper arms), sunburn, raised moles and scars, open sores at application site (upper arms), scar tissue, tattoo, or coloration that would interfere with placement of products, skin assessment, or reactions to rivastigmine
  22. BMI ≥30 kg/m2

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): NCT03915626


Contacts
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Contact: Danielle Fox 443-890-1020 danielle.fox@rx.umaryland.edu

Locations
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United States, Maryland
General Clinical Research Center (GCRC) at the University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Danielle Fox         
Sponsors and Collaborators
University of Maryland, Baltimore
Food and Drug Administration (FDA)
Investigators
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Principal Investigator: Audra L Stinchcomb, PhD University of Maryland, Baltimore School of Pharmacy
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Responsible Party: Audra Stinchcomb, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03915626    
Other Study ID Numbers: HP-00076010
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents