Effect of Heat on Rivastigmine TDS Products

NCT03915626 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: HP-00076010
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability

Outcome Measures

Primary Outcomes (1)

• Total Area Under the Curve (AUC) 0-12 Hours

  Blood samples were obtained at the following time points: -60 min (before patch application) and then 2 h, 3 h, 4 h, 5 h, 5 h 15 min, 5 h 30 min, 5 h 45 min, 6 h, 6 h 15 min, 6 h 30 min, 6 h 45 min, 7 h, 7 h 30 min, 8 h, 8 h 30 min, 9 h, 9 h 15 min, 9 h 30 min, 10 h, 11 h, 12 h post patch administration.

  0-12 hours for each subject for each of the four study sessions

Study Arms (4)

RLD patch

EXPERIMENTAL

RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours

Drug: Rivastigmine (RLD) transdermal patch

generic patch

EXPERIMENTAL

generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours

Drug: Rivastigmine (generic) transdermal patch

RLD patch with heat

EXPERIMENTAL

RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application

Drug: Rivastigmine (RLD) transdermal patch

generic patch with heat

EXPERIMENTAL

generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application

Drug: Rivastigmine (generic) transdermal patch

Interventions

Rivastigmine (RLD) transdermal patch DRUG

brand name patch

Also known as: brand name patch

RLD patch; RLD patch with heat

Rivastigmine (generic) transdermal patch DRUG

generic patch

Also known as: generic patch

generic patch; generic patch with heat

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or non-pregnant, non-lactating women who are of any ethnic background between the age of 18 to 45 years old
• 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
• Provide written informed consent before initiation of any of the study procedures
• 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
• Able to adhere to the study restrictions and protocol schedule
• Able to participate in all study sessions
• Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination and medication history
• Negative urine drug screening test (cannabinoids, amphetamines, barbiturates, benzodiazepine, cocaine, methadone, opiates, PCP)
• 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)
• Have normal screening laboratories for urine protein and urine glucose
• 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
• Agree not to donate blood to a blood bank throughout participation in the study and for at least three months after last procedure day
• 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)
• Have normal vital signs:
• Temperature 35-37.9°C (95-100.3°F)

You may not qualify if:

• 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
• 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)
• Participation in any ongoing investigational drug trial/study or clinical drug trial/study
• History of lung, heart, respiratory or blood disease
• Active positive Hepatitis B, C and/or HIV serologies
• Positive urine drug screening test
• 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)
• Donation or loss of greater than one pint of blood within 60 days of entry to the study
• Any prior allergies to rivastigmine, other carbamate derivatives, other ingredients in the patch, to medical tape products or other skin patches
• Subject has problems with urinary retention, gastric retention or gastrointestinal obstruction
• Subject has continuous spasms, muscle contractions, motor restlessness, rigidity, slowness of movement, tremors or irregular jerky movements
• Subject has ulcers or gastrointestinal bleeding
• Subject has asthma or blocked airflow making it hard to breathe (COPD)
• 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
• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

General Clinical Research Center (GCRC) at the University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Rivastigmine; Transdermal Patch; Drugs, Generic

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Equipment and Supplies; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Audra L. Stinchcomb
• Organization: University of Maryland, Baltimore School of Pharmacy

astinchc@rx.umaryland.edu

410-706-2646

Study Officials

• Audra L Stinchcomb, PhD

  University of Maryland, Baltimore School of Pharmacy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The same healthy subjects are assigned to all four treatments.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: April 16, 2019
• Study Start: October 4, 2019
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: April 4, 2022
• Results First Posted: March 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)