HealthyPhase 4NCT03310970
Pharmacokinetics of Lidocaine in Healthy Adults
A Phase 4 study testing Lidocaine 5% patch, Lidocaine hydrochloride and Lidoderm 5% patch in people with Healthy, run by Nicole K Brogden at 1 site in United States.
Trial summary
The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Lidoderm® topical patch (manufactured by Endo Pharmaceuticals) and the lidocaine 5% patch (manufactured by Mylan Pharmaceuticals) in healthy adults… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lidocaine 5% patch, Lidocaine hydrochloride and Lidoderm 5% patch
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2018to 9 Oct 2019
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or non-pregnant women, of any ethnic background, between the age of 18 and 65 years old.
- Provide written informed consent before initiation of any study procedures.
- Available for follow-up for the planned duration of the study.
- Able to communicate well with the investigators.
- Demonstrate comprehension of the protocol procedures and knowledge of study, as demonstrated by a study member filling out a consent checklist form to verify that the subject understands all aspects of the study including the purpose, procedures, risks and benefits.
- Able to adhere to the study protocol schedule, study restrictions and examination schedule.
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- Subjects must be non-smokers and not regular users of tobacco. They must have refrained from regular and habitual use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 12 months and must have not used any nicotine-containing products in the previous 30 days.
- Subjects who are within their ideal body weight (BMI between 18-29.9 kg/m2).
- Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI), as determined by medical history, physical examination, and medication history.
- Negative urine drug screening test.
- Have a normal blood pressure (systolic: 90-139 mmHg; diastolic: 60-89 mmHg) and heart rate (55-100 bpm).
- Have normal screening laboratories for WBC, Hgb, Hct, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT, AST.
- Female subjects must be of non-childbearing potential. This is defined as surgically sterile (i.e. history of hysterectomy or tubal ligation), or postmenopausal for more than 1 year (no bleeding for 12 consecutive months). If the person is of childbearing potential they must be non-pregnant at the time of enrollment and on the morning of the first day of each study treatment procedure day (a urine pregnancy test will be administered if it has been >30 days since serum pregnancy test for enrollment). The person must also agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner.
- Agrees not to participate in another clinical study during the study period unless the study is in the follow-up phase and it has been one month since the subject received any experimental agents or treatments. The subject also agrees not to participate in an investigational drug study for at least 30 days after last procedure day.
- Agrees not to donate blood to a blood bank throughout participation in the study and for at least 60 days after last procedure day.
- Have a normal ECG; must not have any of the following: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block, advanced A-V heart block, non-sinus rhythm, excluding isolated premature atrial contractions (sinus rhythm is not between 55-100 beats per minute), or any other abnormality that, in the opinion of the MAI, makes it unsafe for the subject to participate in the study.
Who cannot join
- Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or positive urine pregnancy test at any time during the study.
- Smokers. A "smoker", for the purposes of the study, will be defined as an individual who has regularly and habitually used nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the past 12 months. Occasional recreational use (less than once monthly) will not warrant exclusion unless the individual has used nicotine-containing substances in the previous 30 days before study enrollment.
- Participation in any ongoing investigational drug trial or clinical drug trial period unless the study is in the follow-up phase and it has been ≥ one month since the subject received any experimental agents or treatments.
- Abnormal vital signs, defined as:
- Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) at rest on two separate days.
- Heart rate <55 at rest on two separate days
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- Respiratory rate ≤ 11 to ≥ 18 breaths per minute
- Temperature >38.0ºC (100.4ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within seven days of administration of a study product.
- History of chronic obstructive pulmonary disease.
- Positive urine drug screening test.
- Use of any prescription medication during the period 0 to 30 days or over-the counter medication during the period 0 to 3 days before entry to the study (vitamins, herbal supplements and birth control medications will be allowed).
- Use of medications or treatments that would significantly influence or exaggerate responses to the test product or that would alter inflammatory or immune response to the product. This includes antihistamines (within 72 hours prior to dosing), systemic or topical corticosteroids within four weeks prior to dosing, use of monoamine oxidase inhibitors 21 days prior to study, cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin [BCG], monoclonal antibodies, or radiation therapy.
- Donation or loss of greater than one pint of blood within 60 days of entry to the study.
- Any prior serious adverse reaction or hypersensitivity to lidocaine administered by any route.
- Current diagnosis of any major psychiatric illness.
- Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days before enrollment in this study or expects to receive an experimental agent during the study.
- Medical history of a serious chronic condition, including (but not limited to): allergic conditions such as anaphylaxis to food or drugs; asthma; generalized drug reactions; any seizure disorder; any central nervous system disorder; glaucoma (open or closed angle); history of pyloric or urinary bladder neck obstruction; intestinal obstruction; difficulty swallowing; stomach or bowel problems (e.g, blockage, muscle weakness, ulcerative colitis, Crohn's disease); bleeding disorders; acid reflux disease; myasthenia gravis; allergy to belladonna alkaloids; impaired hepatic or renal function.
- Any condition that would, in the opinion of the Principal Investigator (PI) or MAI, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Inability to communicate or cooperate with the investigators.
- Medical history of significant dermatologic diseases or conditions, such as atopy, psoriasis, vitiligo or conditions known to alter skin appearance or physiologic response (e.g. diabetes, porphyria).
- History of significant dermatologic cancers (e.g. melanoma, squamous cell carcinoma), except basal cell carcinomas that were superficial and did not involve the investigative site.
- History of consumption of alcohol within 24 hours prior to dose administration.
- Subject has an obvious difference in skin color at patch sites (compared to neighboring skin), or the presence of a skin condition, excessive hair at the application site, sunburn, raised moles and scars, open sores at application site, scar tissue, tattoo, or coloration that would interfere with placement of test articles, or the assessment of the skin and/or reactions to drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Absolute Bioavailability/Pharmacokinetic and Residual Drug Analysis of Topical Lidocaine in Healthy Adults
The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Lidoderm® topical patch (manufactured by Endo Pharmaceuticals) and the lidocaine 5% patch (manufactured by Mylan Pharmaceuticals) in healthy adults, and to ensure the safety of individuals utilizing these types of products.
Read the detailed description
Topical drug delivery systems in the form of patches are convenient, attractive, and easy to use. Lidocaine is a very popular patch available on the United States market today. Accurate determination of the rate and extent of drug release and absorption is crucial to ensure the safety of individuals using these and other types of patches. The drug delivery rate can be determined early in the development process by using in vitro skin flux permeation studies, and later in humans by accurately quantifying residual drug from patches post-wear and in pharmacokinetic studies. In this study the investigators will employ two types of evaluation to determine the rate and extent of drug release and absorption from lidocaine patches, namely residual drug analysis post-wear and pharmacokinetic analysis in healthy adult volunteers. In addition, the investigators will compare the serum drug concentrations following patch and intravenous administration in order to determine the absolute bioavailability of these patches. Positive outcomes of this project will identify appropriate methods to determine the rate and extent of drug release and absorption from topical patches, and will help regulatory agencies in the development of Guidances for Industry regarding the characterization of drug release and absorption kinetics to ensure the safety of individuals utilizing these types of products.
- Conditions
- Healthy
- Being tested
- Lidocaine 5% patch, Lidocaine hydrochloride, Lidoderm 5% patch
- Keywords
- Peer Reviewed Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 5% patchDrug
Each subject will wear three generic Lidocaine 5% topical patches for 12 hours.
Lidocaine hydrochlorideDrug
Each subject will receive a dose of 0.5 mg/kg intravenously over a period of 5 minutes.
Lidoderm 5% patchDrug
Each subject will wear three Lidoderm® topical patches for 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine 5% patch | Active comparator | Each subject will wear three generic Lidocaine 5% topical patches for 12 hours. Receives: Drug: Lidocaine 5% patch |
| Lidoderm® 5% patch | Active comparator | Each subject will wear three Lidoderm® topical patches for 12 hours. Receives: Drug: Lidoderm 5% patch |
| Intravenous lidocaine | Active comparator | A single intravenous dose of 0.5 mg/kg lidocaine hydrochloride will be administered to each subject. Receives: Drug: Lidocaine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Maximum Serum Concentration of Lidocaine (Cmax)
Cmax is the highest lidocaine concentration measured in the serum.
Measured: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Secondary outcomes (5)
Measurement of Volume of Lidocaine Distribution (V)
Volume of distribution is a mathematical concept that relates the amount of lidocaine in the body to the concentration of lidocaine measured in the serum.
Measured: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Measurement of Time of Maximum Serum Lidocaine Concentration (Tmax).
Tmax is the time point at which the maximum drug concentration in serum is measured.
Measured: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Measurement of Elimination Rate Constant of Lidocaine (Kel)
The elimination rate constant is a mathematical value describing the rate at which lidocaine is removed from the body.
Measured: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Determination of Area Under the Serum-concentration-time Curve (AUC)
Area under the serum-concentration-time curve is a mathematical measure of total systemic exposure to lidocaine in the body.
Measured: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Residual Drug Analysis in Worn TDDS and Patches
The amount of drug remaining in the patches is measured after the patches have been worn and removed. This outcome is only reported for the patch arms of the study and is not applicable to the intravenous arm.
Measured: Measured after patches are removed from subjects following 12 hours of patch wear.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start14 Mar 2018
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
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 HealthyStudies of the same condition, open and under way.
- 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
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicole K Brogden
- Sponsor type
- University, hospital or other
- Collaborators
- Long Island University
- Responsible party
- Sponsor-investigator, Nicole K Brogden, University of Iowa
- Investigators
- Nicole K Brogden, PharmD, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310970
- Sponsor's protocol ID
- 201701725
- Status last verified
- Oct 2021
- First submitted
- 10 Oct 2017
- Last updated
- 1 Nov 2021
- 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 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absolute Bioavailability/Pharmacokinetic and Residual Drug Analysis of Topical Lidocaine in Healthy Adults
- ClinicalTrials.gov ID
- NCT03310970
- Acronym / sponsor ID
- 201701725
- Conditions
- Healthy
- Keywords
- Peer Reviewed Research
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Nicole K BrogdenUniversity, hospital or other
- Collaborators
- Long Island University
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Posted 1 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery of Lidoderm® topical patch (manufactured by Endo Pharmaceuticals) and the lidocaine 5% patch (manufactured by Mylan Pharmaceuticals) in healthy adults, and to ensure the safety of individuals utilizing these types of products.
Detailed description
Topical drug delivery systems in the form of patches are convenient, attractive, and easy to use. Lidocaine is a very popular patch available on the United States market today. Accurate determination of the rate and extent of drug release and absorption is crucial to ensure the safety of individuals using these and other types of patches. The drug delivery rate can be determined early in the development process by using in vitro skin flux permeation studies, and later in humans by accurately quantifying residual drug from patches post-wear and in pharmacokinetic studies. In this study the investigators will employ two types of evaluation to determine the rate and extent of drug release and absorption from lidocaine patches, namely residual drug analysis post-wear and pharmacokinetic analysis in healthy adult volunteers. In addition, the investigators will compare the serum drug concentrations following patch and intravenous administration in order to determine the absolute bioavailability of these patches. Positive outcomes of this project will identify appropriate methods to determine the rate and extent of drug release and absorption from topical patches, and will help regulatory agencies in the development of Guidances for Industry regarding the characterization of drug release and absorption kinetics to ensure the safety of individuals utilizing these types of products.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 5% patch | Active comparator | Drug: Lidocaine 5% patchEach subject will wear three generic Lidocaine 5% topical patches for 12 hours. |
| Lidoderm® 5% patch | Active comparator | Drug: Lidoderm 5% patchEach subject will wear three Lidoderm® topical patches for 12 hours. |
| Intravenous lidocaine | Active comparator | Drug: Lidocaine hydrochlorideA single intravenous dose of 0.5 mg/kg lidocaine hydrochloride will be administered to each subject. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men or non-pregnant women, of any ethnic background, between the age of 18 and 65 years old.
- Provide written informed consent before initiation of any study procedures.
- Available for follow-up for the planned duration of the study.
- Able to communicate well with the investigators.
- Demonstrate comprehension of the protocol procedures and knowledge of study, as demonstrated by a study member filling out a consent checklist form to verify that the subject understands all aspects of the study including the purpose, procedures, risks and benefits.
Key exclusion criteria (23 listed)
- Women who are pregnant or lactating or have a positive serum pregnancy test at enrollment or positive urine pregnancy test at any time during the study.
- Smokers. A "smoker", for the purposes of the study, will be defined as an individual who has regularly and habitually used nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the past 12 months. Occasional recreational use (less than once monthly) will not warrant exclusion unless the individual has used nicotine-containing substances in the previous 30 days before study enrollment.
- Participation in any ongoing investigational drug trial or clinical drug trial period unless the study is in the follow-up phase and it has been ≥ one month since the subject received any experimental agents or treatments.
- Abnormal vital signs, defined as:
- Temperature >38.0ºC (100.4ºF) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within seven days of administration of a study product.
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 |
|---|---|---|
| Lidocaine 5% patchEach subject will wear three generic Lidocaine 5% topical patches for 12 hours. | Drug | Lidocaine 5% patch |
| Lidocaine hydrochlorideEach subject will receive a dose of 0.5 mg/kg intravenously over a period of 5 minutes. | Drug | Intravenous lidocaine |
| Lidoderm 5% patchEach subject will wear three Lidoderm® topical patches for 12 hours. | Drug | Lidoderm® 5% patch |
Primary outcome
Measurement of Maximum Serum Concentration of Lidocaine (Cmax)
Time frame: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Cmax is the highest lidocaine concentration measured in the serum.
5 secondary outcomes
Measurement of Volume of Lidocaine Distribution (V)
Time frame: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Measurement of Time of Maximum Serum Lidocaine Concentration (Tmax).
Time frame: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Measurement of Elimination Rate Constant of Lidocaine (Kel)
Time frame: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Determination of Area Under the Serum-concentration-time Curve (AUC)
Time frame: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.
Residual Drug Analysis in Worn TDDS and Patches
Time frame: Measured after patches are removed from subjects following 12 hours of patch wear.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- 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.
Nicole K Brogden, PharmD, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine 5% patch, Lidocaine hydrochloride and Lidoderm 5% patch in people with Healthy, run by Nicole K Brogden 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 16 inclusion and 23 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 1 Nov 2021. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 1 Nov 2021). 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?
Measurement of Maximum Serum Concentration of Lidocaine (Cmax) (time frame: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.). 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 1 Nov 2021.