HealthyPhase 1NCT05006118

Pharmacokinetics and Excretion of Oral [14C]-Rodatristat Ethyl

A Phase 1 study testing Radio-labeled rodatristat ethyl 600 mg in people with Healthy, run by Altavant Sciences GmbH at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-label study to evaluate the PK and excretion of a single oral dose of [14C]-rodatristat ethyl. The study will consist of: Screening evaluations (within 29 days prior to dosing); a treatment phase (from dosing until discharge from the unit, a minimum of 7 days and a maximum of 14 days); and discharge… Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Radio-labeled rodatristat ethyl 600 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 23 Sep 2021to 6 Oct 2021
Phase: Phase 1
Are there results?: None posted in the registry

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 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males aged 18 to 55 years, inclusive.
Healthy subjects are defined as individuals free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, cardiac monitoring, and clinical laboratory test results.
Male subjects must agree to use contraception as detailed in Section 5.4.1 starting at Screening, during the treatment period, and for at least 100 days after the last dose of investigational product (IP), and refrain from donating sperm during this period.
Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2
Capable of giving signed informed consent, able to understand and comply with protocol requirements, instructions, and protocol-related restrictions, and likely to complete the study as planned.
History of regular bowel movements (averaging one or more bowel movements per day).

Who cannot join

Any known preexisting medical or psychiatric condition that could interfere with the subject's ability to provide informed consent or participate in study conduct, or that may confound study findings including, but not limited to a history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, or cardiovascular disease
History of Gilbert's Syndrome
History of any allergy that, in the opinion of the Investigator, contraindicates participation in the trial.
Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at Screening) of 50 mL to 499 mL of blood within 30 days or more than 499 mL within 56 days prior to Day 1.
Participation in an investigational drug, vaccine, or device study, where last administration of the investigational drug (new chemical entity) is within 30 days or 5 half-lives whichever is longer before IP administration or 90 days for a biologic study.
Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy (e.g., cholecystectomy) or motility, or with abnormal hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the IP (appendectomy and hernia repair would be acceptable).

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Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months (previous study to be at least 4 months prior to check-in to the study site where exposures are known to the Investigator or 6 months prior to check-in to the study site for a radiolabeled drug study where exposures are not known to the Investigator).
Clinically significant ECG abnormalities (i.e., QTcF > 450 msec) prior to dosing (Screening and Day -1) that are confirmed by a repeat reading.
Abnormal blood pressure, either low (defined as < 90 mmHg systolic and/or < 50 mmHg diastolic) or high (defined as > 140 mmHg systolic and/or > 90 mmHg diastolic) at Screening or Day -1 that is confirmed by a repeat reading.
Clinically significant abnormalities in laboratory test results (hematology, coagulation, chemistry panel, and urinalysis) at Screening or Day -1 that are confirmed by a repeat reading
Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at Screening. Subjects who test positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) also will be ineligible. Evidence of prior HBV vaccination (positive hepatitis B surface antibody [HBsAb]) is not exclusionary.
Creatinine clearance < 80 mL/min at Screening or Day -1, calculated using the Cockcroft-Gault formula.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values greater than upper limit of normal (ULN) at Screening or Day -1. A single repeat measurement is allowed for eligibility determination.
Positive urine test for drugs of abuse (including cotinine) at Screening or Day 1.
Positive alcohol test (breath, saliva, or urine) at Day 1.
Use of prescription or nonprescription drugs, including high dose vitamins, dietary supplements (including St. John's Wort) within 7 days or 5 halflives of the prescription or nonprescription drug (whichever was longer) prior to the first dose of IP, unless in the opinion of the Investigator and Sponsor, the medication would not interfere with the study outcomes or compromise subject safety.
Consumption of grapefruit or Seville oranges or their juices within the 7 days prior to dosing until collection of the final PK sample.
Use of medications associated with QT prolongation within 30 days prior to dosing and during the study. A list of prohibited medications is provided in an appendix to the protocol.
Covid-19 vaccine within the 7 days prior to dosing and during the study.
Subjects unable to abstain from alcohol for 72 hours prior to the start of dosing through collection of the final PK sample.
Subjects with a clinical history of or current alcohol abuse defined as an average weekly intake of more than 21 units (1 unit = 340 mL beer, 115 mL wine, or 43 mL spirits).
Subjects with a clinical history of or current illicit drug use which, in the opinion of the Investigator, would interfere with the subject's ability to complete the study and could compromise subject safety and/or the results of the study.
Subjects unable to abstain from caffeine, xanthine, or strenuous exercise for 72 hours prior to dosing until collection of the final PK sample.
Subjects who have smoked or used tobacco or nicotine containing products or cannabidiol and related products (in all forms) within 3 months prior to the Screening Visit and who are unwilling to refrain from such products for the entire duration of the study (through the Followup Visit).
Employed as site personnel directly involved with this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Unit
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: An Open-Label Mass Balance Study to Investigate the Pharmacokinetics, Excretion, and Recovery of Single-Dose Oral [14C]-Rodatristat Ethyl in Healthy Male Subjects

Read the detailed description

After meeting eligibility criteria, approximately 6 healthy male subjects will check into the clinical unit (Day -1), and the following morning, receive a single oral suspension of rodatristat ethyl 600 mg containing a mixture of [12C]-rodatristat ethyl and [14C]-rodatristat ethyl to contain approximately 600 microcuries (μCi) of radioactivity (Day 1). After fasting 10 hours overnight, the dose will be administered with a standard-calorie meal. Following dosing, serial whole blood and plasma PK samples, and urine and feces will be collected until discharge. Subjects will stay in the clinic until at least Day 7. Subjects will be discharged if total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected. If not, subjects will remain in the clinic until these criteria are met but not longer than 15 days (which includes Day -1). Plasma and urine samples will be analyzed for total radioactivity, rodatristat ethyl, rodatristat, M15, and any other identified metabolites (if applicable). Blood and fecal samples will be analyzed for total radioactivity, rodatristat ethyl, rodatristat, and metabolite(s).

Conditions: Healthy
Being tested: Radio-labeled rodatristat ethyl 600 mg
Keywords: Pulmonary Arterial Hypertension, PAH
Medical subject headings: Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radio-labeled rodatristat ethyl 600 mgDrug
Single dose of rodatristat ethyl 600 mg as an oral suspension containing a mixture of [12C]-rodatristat ethyl and [14C]-rodatristat ethyl to contain approximately 600 microcuries (uCi) of radioactivity

Study groups in NCT05006118
Study group	Role	What they receive
Radio-labeled rodatristat ethyl 600 mg	Experimental	Single dose of rodatristat ethyl 600 mg as an oral suspension containing a mixture of [12C]-rodatristat ethyl and [14C]-rodatristat ethyl to contain approximately 600 microcuries (uCi) of radioactivity Receives: Drug: Radio-labeled rodatristat ethyl 600 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall, urinary, and fecal recovery of total radioactivity as a percentage of administered dose.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected

Secondary outcomes (14)

Plasma AUC(0-t) of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Plasma AUC(0-∞) of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Plasma Cmax of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Plasma tmax of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Plasma CL/F of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Amount excreted (Ae) of total radioactivity, rodatristat ethyl, rodatristat, and M15.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Renal clearance (CLR) of total radioactivity, rodatristat ethyl, rodatristat, and M15.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood AUC(0-t) of total radioactivity.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood AUC(0-∞) of total radioactivity.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood Cmax of total radioactivity.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood tmax of total radioactivity.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood t½ of total radioactivity.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood CL/F of total radioactivity.
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Identification and characterization of rodatristat ethyl metabolite(s) in plasma, urine, and feces if applicable (may be reported separately).
Measured: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 20216 Oct 2021

First posted16 Aug 2021
Study start23 Sep 2021
Primary completion6 Oct 2021
Study completion6 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05006118
Sponsor's protocol ID: RVT-1201-1003
Status last verified: Jul 2022
First submitted: 28 Jul 2021
Last updated: 13 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Mass Balance Study to Investigate the Pharmacokinetics, Excretion, and Recovery of Single-Dose Oral [14C]-Rodatristat Ethyl in Healthy Male Subjects
ClinicalTrials.gov ID: NCT05006118
Acronym / sponsor ID: RVT-1201-1003
Conditions: Healthy
Keywords: Pulmonary Arterial Hypertension, PAH
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Altavant Sciences GmbHIndustry (pharma, biotech, devices)
Collaborators: Covance
Study start: 23 Sep 2021 (actual)
Primary completion: 6 Oct 2021 (actual)
Study completion: 6 Oct 2021 (actual)
First posted: 16 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Radio-labeled rodatristat ethyl 600 mg	Experimental	Drug: Radio-labeled rodatristat ethyl 600 mgSingle dose of rodatristat ethyl 600 mg as an oral suspension containing a mixture of [12C]-rodatristat ethyl and [14C]-rodatristat ethyl to contain approximately 600 microcuries (uCi) of radioactivity

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy males aged 18 to 55 years, inclusive.
Healthy subjects are defined as individuals free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, cardiac monitoring, and clinical laboratory test results.
Male subjects must agree to use contraception as detailed in Section 5.4.1 starting at Screening, during the treatment period, and for at least 100 days after the last dose of investigational product (IP), and refrain from donating sperm during this period.
Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2
Capable of giving signed informed consent, able to understand and comply with protocol requirements, instructions, and protocol-related restrictions, and likely to complete the study as planned.

Key exclusion criteria (25 listed)

Any known preexisting medical or psychiatric condition that could interfere with the subject's ability to provide informed consent or participate in study conduct, or that may confound study findings including, but not limited to a history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, or cardiovascular disease
History of Gilbert's Syndrome
History of any allergy that, in the opinion of the Investigator, contraindicates participation in the trial.
Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at Screening) of 50 mL to 499 mL of blood within 30 days or more than 499 mL within 56 days prior to Day 1.
Participation in an investigational drug, vaccine, or device study, where last administration of the investigational drug (new chemical entity) is within 30 days or 5 half-lives whichever is longer before IP administration or 90 days for a biologic study.

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
Radio-labeled rodatristat ethyl 600 mgSingle dose of rodatristat ethyl 600 mg as an oral suspension containing a mixture of [12C]-rodatristat ethyl and [14C]-rodatristat ethyl to contain approximately 600 microcuries (uCi) of radioactivity	Drug	Radio-labeled rodatristat ethyl 600 mg

Primary outcome

Overall, urinary, and fecal recovery of total radioactivity as a percentage of administered dose.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected

14 secondary outcomes

Plasma AUC(0-t) of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Plasma AUC(0-∞) of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Plasma Cmax of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Plasma tmax of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Plasma CL/F of total radioactivity, rodatristat ethyl, rodatristat, M15, and other metabolites if appropriate.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Amount excreted (Ae) of total radioactivity, rodatristat ethyl, rodatristat, and M15.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Renal clearance (CLR) of total radioactivity, rodatristat ethyl, rodatristat, and M15.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood AUC(0-t) of total radioactivity.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood AUC(0-∞) of total radioactivity.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood Cmax of total radioactivity.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood tmax of total radioactivity.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood t½ of total radioactivity.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Blood CL/F of total radioactivity.
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected
Identification and characterization of rodatristat ethyl metabolite(s) in plasma, urine, and feces if applicable (may be reported separately).
Time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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.

John E Blanchard, MD principal investigator

Covance Clinical Research Unit

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Radio-labeled rodatristat ethyl 600 mg in people with Healthy, run by Altavant Sciences GmbH 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 6 inclusion and 25 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 13 Jul 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall, urinary, and fecal recovery of total radioactivity as a percentage of administered dose. (time frame: 15 days or until total recovery (urine and feces combined) of the administered radioactive dose is ≥90% and the total daily recovery of radioactive dose is ≤1% on 2 consecutive days in which a fecal sample is collected). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05006118.

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 13 Jul 2022.