BioavailabilityEarly Phase 1NCT03915626
Effect of Heat on Rivastigmine TDS Products
A Early Phase 1 study testing Rivastigmine (RLD) transdermal patch and Rivastigmine (generic) transdermal patch in people with Bioavailability, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Rivastigmine (RLD) transdermal patch and Rivastigmine (generic) transdermal patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2019to 4 May 2021
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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)
- 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
Who cannot join
- 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
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- 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
- Consumption (food or drink) of alcohol within 24 h prior to dose administration
- 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)
- History of diabetes
- Hereditary skin disorders or any skin inflammatory conditions as reported by the subject or evident to the MAI
- 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
- 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
- BMI ≥30 kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Research Center (GCRC) at the University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Determination of Serum Rivastigmine Levels After Using Rivastigmine Transdermal Delivery Systems With and Without Standardized Heat Application in Healthy Human Volunteers
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
- Being tested
- Rivastigmine (RLD) transdermal patch, Rivastigmine (generic) transdermal patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivastigmine (RLD) transdermal patchDrug
Also called brand name patch
brand name patch
Rivastigmine (generic) transdermal patchDrug
Also called generic patch
generic patch
| Study group | Role | What they receive |
|---|---|---|
| RLD patch | Experimental | RLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours Receives: Drug: Rivastigmine (RLD) transdermal patch |
| generic patch | Experimental | generic rivastigmine patch (4.6 mg/24 hours); worn for 9 hours Receives: 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 Receives: 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 Receives: Drug: Rivastigmine (generic) transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-12 hours for each subject for each of the four study sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start4 Oct 2019
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The same healthy subjects are assigned to all four treatments.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Audra Stinchcomb, University of Maryland, Baltimore
- Investigators
- Audra L Stinchcomb, PhD, Principal investigator, University of Maryland, Baltimore School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915626
- Sponsor's protocol ID
- HP-00076010
- Status last verified
- Apr 2022
- First submitted
- 5 Mar 2019
- Last updated
- 4 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Serum Rivastigmine Levels After Using Rivastigmine Transdermal Delivery Systems With and Without Standardized Heat Application in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT03915626
- Acronym / sponsor ID
- HP-00076010
- Conditions
- Bioavailability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Posted 7 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The same healthy subjects are assigned to all four treatments.
| Arm | Type | Receives |
|---|---|---|
| RLD patch | Experimental | Drug: Rivastigmine (RLD) transdermal patchRLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours |
| generic patch | Experimental | Drug: Rivastigmine (generic) transdermal patchgeneric rivastigmine patch (4.6 mg/24 hours); worn for 9 hours |
| RLD patch with heat | Experimental | Drug: Rivastigmine (RLD) transdermal patchRLD rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application |
| generic patch with heat | Experimental | Drug: Rivastigmine (generic) transdermal patchgeneric rivastigmine patch (4.6 mg/24 hours); worn for 9 hours; 90 min heat application |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivastigmine (RLD) transdermal patchAlso: brand name patchbrand name patch | Drug | RLD patch, RLD patch with heat |
| Rivastigmine (generic) transdermal patchAlso: generic patchgeneric patch | Drug | generic patch, generic patch with heat |
Primary outcome
Total Area Under the Curve (AUC) 0-12 Hours
Time frame: 0-12 hours for each subject for each of the four study sessions
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audra L Stinchcomb, PhD principal investigator
University of Maryland, Baltimore School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rivastigmine (RLD) transdermal patch and Rivastigmine (generic) transdermal patch in people with Bioavailability, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Area Under the Curve (AUC) 0-12 Hours (time frame: 0-12 hours for each subject for each of the four study sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.