TuberculosisPhase 1NCT01358162
Phase IC Study of Safety and PK of SQ109 300mg Daily
A Phase 1 study testing SQ109 in people with Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Healthy male and female volunteers will be given SQ109 300mg daily for 14 days to assess the safety and tolerability and pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- SQ109
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Apr 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must be 18 to 45 years of age (inclusive).
- Subject must be a healthy male or female volunteer (i.e., hematology, coagulation, clinical chemistries and urinalysis tests must be within study-defined ranges (See Appendix B). Clinical tests must be performed within 28 days of receiving first dose of study drug.
- Body Mass Index (BMI) must be between 18 and 30 kg/m2 inclusive.
- Subject must be Tuberculin Skin Test/Purified Protein Derivative (TST/PPD) negative (within the previous 1 year) at Screening. The TST/PPD may be omitted if the subject presents written evidence of having a negative test during the previous 12 months.
- Subject must be able to give voluntary written informed consent before any study related procedure is performed.
- If female, has no childbearing potential or agrees to avoid becoming pregnant from the day of screening through their entire participation in the trial (Day 28) by using one of the following acceptable methods of birth control plus recommended use of a barrier method (condom) by the male partner (even if vasectomized):
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- intrauterine contraceptive device; or
- diaphragm in combination with contraceptive jelly, cream, or foam; or
- spermicide; or
- abstinence. Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy or status after hysterectomy.
- Hormonal contraceptives of any type or form (including oral, transdermal, vaginal or depot preparations) will not be allowed during the study.
- All female subjects of childbearing potential must have a negative serum pregnancy test at screening and within 24 hours of the first dose of study product.
- Male subjects must agree to use an acceptable barrier method for birth control (abstinence or use of a condom with spermicide) from screening through Study Day 28 and advice and recommend use of additional birth control (as in criterion 6 above) to female sex partners throughout the study.
- Subject agrees not to donate blood during the study and up to 30 days after Study Day 28.
- Subject agrees to comply with all study requirements, including clinic house rules.
Who cannot join
- A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principal Investigator (PI), would jeopardize the safety of the subject or impact the validity of the study results.
- Subject has been on an abnormal diet during the 4 weeks preceding the study. Abnormal diet is defined as a diet in which the subject has a significant change in eating habits (e.g., liquid diet only) and an unbalanced diet (e.g., protein only, high fat, low carbohydrate, etc.).
- Subject has received an investigational drug in a clinical trial within 30 days prior to study initiation.
- Subject has used any OTC medication, including vitamins and herbal supplements, within 7 days prior to Day 1 of the study, unless in the opinion of the PI, the substance would not likely impact on the conduct of this study, including PK of SQ109.
- Subject has used any prescription medication within 14 days prior to Day 1 of the study, or the use of hormonal preparations containing sex hormones within 30 days prior to Day 1 of the study.
- Subject has any current medical condition requiring treatment with medication, either prescription or OTC.
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- Subject has been treated with any known CYP450 enzyme altering drugs such as azoles, antifungals, barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to Day 1 of the study.
- Subject has a positive blood screen for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody and/or a positive history for alcohol abuse or dependence and/or a positive serum ethanol or a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine metabolites, marijuana, opiates, phencyclidine (PCP)).
- Subject has a baseline QTcF interval >450 msec (males) or >470 msec (females) (defined in Section 9.1.3) or a family history of prolonged QTcF syndrome or premature cardiac death.
- Subject has Wolf Parkinson White Syndrome (WPW) or family history of WPW or a history of supra-ventricular tachycardias or syncope.
- Subject has lived with a person having active TB or has traveled to an area of endemic TB within the past 12 months.
- Subject has an abnormal result on the Ishihara color test, the funduscopic exam, current optic neuritis or known retinal disease.
- Subject has an uncontrolled intercurrent illness (i.e., active infection) or fever (oral temperature >/=100 degrees F or >/= 37.7 degrees C).
- Subject has had major surgery within 4 weeks of study entry.
- Women who are pregnant or breastfeeding.
- Subject has donated blood within the past 30 days prior to Day 1 of the study.
- Subject has allergy to ethambutol or related compounds.
- Subject is an employee of or family member of an employee of Sequella, Quintiles, or DynPort Vaccine Company LLC (DVC).
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase I Services - Overland Park
Overland Park, Kansas, 66211
About this study
Official title: A Phase 1C, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Safety, Tolerability and Pharmacokinetics of 300 mg of SQ109 Given Once Daily for 14 Days in Normal, Healthy Male and Female Volunteers
Healthy male and female volunteers will be given SQ109 300mg daily for 14 days to assess the safety and tolerability and pharmacokinetics.
Read the detailed description
This is a Phase 1C randomized, placebo controlled, double-blinded, in-patient trial of a single oral dose of 300 mg of SQ109 given daily for 14 consecutive days to evaluate the safety, tolerability and pharmacokinetics of SQ109 in normal healthy male and female subjects 18-45 years of age.
Each subject will receive 300 mg of SQ109 or placebo.
- Conditions
- Tuberculosis
- Being tested
- Placebo, SQ109
- Keywords
- Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo given orally, daily for 14 consecutive days
SQ109Drug
A single oral dose of 300 mg of SQ109 given daily for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| SQ109 | Experimental | 300 mg of SQ109, orally, given daily for 14 consecutive days Receives: Drug: SQ109 |
| Placebo | Placebo comparator | Placebo given orally, daily for 14 consecutive days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & tolerability via: physical exams, color and visual acuity tests, funduscopic exams, neurological exams, vital signs, electrocardiograms, routine clinical labs (includes chemistry, hematology, coagulation and urinalysis data), and adverse events.
Measured: Days 1-14, 16-18, 21 and 28
Secondary outcomes (15)
Pharmacokinetics of SQ109: Serial blood samples prior to and following single/multiple doses: AUC(0-t): area under the concentration time curve to the last time with concentration greater than or equal to the validated limit of quantitation of the assay
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on day 1.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: AUC(0-infinity): area under the concentration time curve to infinity
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on day 1.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: AUC(0-24): area under the concentration time curve to 24 hours
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: t1/2: apparent terminal half-life
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1 & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: CL/F: apparent oral clearance
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Vz/F: apparent volume of distribution
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Cmin: observed minimum concentration
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Cavg: calculated average concentration during the dosing interval
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Tmax: Time of maximum concentration (Cmax)
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: AUC(0-tau) Area under the concentration time curve to the end of the dosing interval, 24 hours
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: RCmax: Accumulation ratio for Cmax estimated as Cmax (Day 14) / Cmax (Day 1)
Measured: Before and after dosing on days 1-14. Serial PK after dosing on days 1 & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Tmin: Time to minimum concentration (Cmin)
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Linearity Index: AUC(0-tau) (Day 14) / AUC(0-infinity)(Day 1)
Measured: Before and after dosing on days 1-14. Serial PK after dosing on days 1 & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: RAUC : Accumulation ratio for AUC estimated as AUC0-tau (Day 14)/ AUC(0-24)(Day 1)
Measured: Before and after dosing on days 1-14. Serial PK after dosing on days 1 & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Cmax: observed maximum concentration
Measured: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358162
- Sponsor's protocol ID
- 09-0111
- Other IDs
- N01AI80024C
- Status last verified
- May 2011
- First submitted
- 18 Nov 2010
- Last updated
- 14 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1C, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Safety, Tolerability and Pharmacokinetics of 300 mg of SQ109 Given Once Daily for 14 Days in Normal, Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT01358162
- Acronym / sponsor ID
- 09-0111
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 May 2011 (estimated)
- 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.
Healthy male and female volunteers will be given SQ109 300mg daily for 14 days to assess the safety and tolerability and pharmacokinetics.
Detailed description
This is a Phase 1C randomized, placebo controlled, double-blinded, in-patient trial of a single oral dose of 300 mg of SQ109 given daily for 14 consecutive days to evaluate the safety, tolerability and pharmacokinetics of SQ109 in normal healthy male and female subjects 18-45 years of age.
Each subject will receive 300 mg of SQ109 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SQ109 | Experimental | Drug: SQ109300 mg of SQ109, orally, given daily for 14 consecutive days |
| Placebo | Placebo comparator | Other: PlaceboPlacebo given orally, daily for 14 consecutive days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Subject must be 18 to 45 years of age (inclusive).
- Subject must be a healthy male or female volunteer (i.e., hematology, coagulation, clinical chemistries and urinalysis tests must be within study-defined ranges (See Appendix B). Clinical tests must be performed within 28 days of receiving first dose of study drug.
- Body Mass Index (BMI) must be between 18 and 30 kg/m2 inclusive.
- Subject must be Tuberculin Skin Test/Purified Protein Derivative (TST/PPD) negative (within the previous 1 year) at Screening. The TST/PPD may be omitted if the subject presents written evidence of having a negative test during the previous 12 months.
- Subject must be able to give voluntary written informed consent before any study related procedure is performed.
Key exclusion criteria (18 listed)
- A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principal Investigator (PI), would jeopardize the safety of the subject or impact the validity of the study results.
- Subject has been on an abnormal diet during the 4 weeks preceding the study. Abnormal diet is defined as a diet in which the subject has a significant change in eating habits (e.g., liquid diet only) and an unbalanced diet (e.g., protein only, high fat, low carbohydrate, etc.).
- Subject has received an investigational drug in a clinical trial within 30 days prior to study initiation.
- Subject has used any OTC medication, including vitamins and herbal supplements, within 7 days prior to Day 1 of the study, unless in the opinion of the PI, the substance would not likely impact on the conduct of this study, including PK of SQ109.
- Subject has used any prescription medication within 14 days prior to Day 1 of the study, or the use of hormonal preparations containing sex hormones within 30 days prior to Day 1 of the 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 |
|---|---|---|
| PlaceboPlacebo given orally, daily for 14 consecutive days | Other | Placebo |
| SQ109A single oral dose of 300 mg of SQ109 given daily for 14 consecutive days. | Drug | SQ109 |
Primary outcome
Safety & tolerability via: physical exams, color and visual acuity tests, funduscopic exams, neurological exams, vital signs, electrocardiograms, routine clinical labs (includes chemistry, hematology, coagulation and urinalysis data), and adverse events.
Time frame: Days 1-14, 16-18, 21 and 28
15 secondary outcomes
Pharmacokinetics of SQ109: Serial blood samples prior to and following single/multiple doses: AUC(0-t): area under the concentration time curve to the last time with concentration greater than or equal to the validated limit of quantitation of the assay
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on day 1.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: AUC(0-infinity): area under the concentration time curve to infinity
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on day 1.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: AUC(0-24): area under the concentration time curve to 24 hours
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: t1/2: apparent terminal half-life
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1 & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: CL/F: apparent oral clearance
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Vz/F: apparent volume of distribution
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Cmin: observed minimum concentration
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Cavg: calculated average concentration during the dosing interval
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Tmax: Time of maximum concentration (Cmax)
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: AUC(0-tau) Area under the concentration time curve to the end of the dosing interval, 24 hours
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: RCmax: Accumulation ratio for Cmax estimated as Cmax (Day 14) / Cmax (Day 1)
Time frame: Before and after dosing on days 1-14. Serial PK after dosing on days 1 & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Tmin: Time to minimum concentration (Cmin)
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Linearity Index: AUC(0-tau) (Day 14) / AUC(0-infinity)(Day 1)
Time frame: Before and after dosing on days 1-14. Serial PK after dosing on days 1 & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: RAUC : Accumulation ratio for AUC estimated as AUC0-tau (Day 14)/ AUC(0-24)(Day 1)
Time frame: Before and after dosing on days 1-14. Serial PK after dosing on days 1 & 14.
Pharmacokinetics of SQ109: Serial blood samples for measurement of plasma levels of SQ109 prior to and following single/multiple doses: Cmax: observed maximum concentration
Time frame: Before and after dosing on days 1-14, then on days 16-21 & 28. Serial PK after dosing on days 1, 5, & 14.
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 14 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SQ109 in people with Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 15 inclusion and 18 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 14 May 2013. 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. Some participants in this study may receive a placebo. 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?
Safety & tolerability via: physical exams, color and visual acuity tests, funduscopic exams, neurological exams, vital signs, electrocardiograms, routine clinical labs (includes chemistry, hematology, coagulation and urinalysis data), and adverse events. (time frame: Days 1-14, 16-18, 21 and 28). 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 14 May 2013.