Hepatic ImpairmentPhase 1NCT05112419
A Study to Assess Zibotentan Pharmacokinetics in Participants With Moderate Hepatic and Moderate Renal Impairment
A Phase 1 study testing Zibotentan in people with Hepatic Impairment and Renal Impairment, run by AstraZeneca at 1 site in Bulgaria.
Trial summary
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of zibotentan in patients with moderate hepatic and moderate renal impairment in comparison to a matched healthy control group. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Renal Impairment
- What is being tested?
- Zibotentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBulgaria
- Study dates
- 10 Nov 2021to 15 Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body weight of at least 50 kg and body mass index within the range of 18 and 35 kg/m^2 (inclusive).
- Female of non-childbearing potential or male
- Participants with Moderate Hepatic Impairment and Moderate Renal Impairment only (Cohort 1)
- An estimated glomerular filtration rate (eGFR) in the range of 30 to 45 mL/min/1.73m^2 (inclusive) as determined using the Chronic Kidney Disease Epidemiology Collaboration formula, at Screening. Retesting for eGFR may be repeated twice during Screening Period.
- Confirmed clinical diagnosis of cirrhosis with either ascites or moderate hepatic impairment (Childs-Pugh B). Supporting documents confirming the participant's hepatic impairment must be available. The participant must be classified by the Investigator or usual practitioner as Child-Pugh Class B or having radiographic or clinical evidence of ascites of any grade.
- Stable hepatic impairment (eg, no clinically significant change in signs, symptoms, or laboratory parameters of hepatic disease status within 28 days prior to Screening, as determined by the Investigator or usual practitioner).
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- Healthy Participants only (Cohort 2)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and clinical laboratory tests.
- An eGFR of ≥ 90 mL/min/1.73m^2 as determined using the CKD-EPI formula at Screening.
- No clinically significant liver or kidney disease as judged by the Investigator.
Who cannot join
- Medical Conditions
- Any evidence of a clinically significant disease which in the Investigator's opinion makes it undesirable for the participant to participate in the study.
- History of alcohol abuse or excessive intake of alcohol within 6 months prior to the Screening visit. Definition of excessive intake: an average weekly intake of >7 drinks/week for men or > 3.5 drinks/week for women. One drink is equivalent to (16 g of alcohol).
- Positive alcohol or drug of abuse at Screening.
- Participants with a history of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, to drugs with a similar chemical structure or class to zibotentan.
- Participants with known hypersensitivity/allergic reaction to paracetamol.
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- Any signs or confirmation of coronavirus disease-19 infection.
- Participants with Moderate Hepatic Impairment and Moderate Renal Impairment only (Cohort 1)
- Presence of unstable medical (eg, diabetes, epilepsy) or psychological conditions which, in the opinion of the Investigator, would compromise the participant's safety or successful participation in this study.
- Fluctuating or rapidly deteriorating hepatic function, as indicated by strongly varying or worsening of clinical and/or laboratory signs of hepatic impairment within 28 days prior to dosing (eg, infection of ascites, fever, or active gastrointestinal bleeding).
- Severe hepatic impairment (Child-Pugh Class C Hepatic impairment), an isolated aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 5 x the upper limit of normal (ULN); or total bilirubin > 2 x ULN at time of enrolment or a concurrent increased AST and ALT of > 3 x the ULN together with a total bilirubin of > 2 x ULN. An isolated increase in bilirubin in participants with known Gilbert's syndrome is not a reason for exclusion.
- Acute liver disease caused by drug toxicity or by an infection.
- Presence of a hepatocellular carcinoma.
- Liver or renal transplantation or planned within the next 3 months at Screening.
- Receiving renal replacement therapy.
- Recent acute or subacute renal function deterioration (eg, participants with large fluctuations of creatinine values, as judged by the Investigator, and documented within 28 days prior to Screening).
- New York Heart Association functional heart failure Class III or intravenous or with unstable heart failure requiring hospitalisation for optimisation of heart failure treatment and who are not yet stable on heart failure therapy within 6 months prior to Screening.
- Abnormal resting vital signs (after resting for 10 minutes) of supine systolic blood pressure> 180 mmHg or < 100 Hg; or diastolic blood pressure> 110 mmHg or < 50 mmHg.
- Change in dose regimen of medically-required medication within the 14 days before dosing.
- Healthy Participants only (Cohort 2)
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Prior/Concomitant Therapy
- Use of strong or moderate inhibitors or inducers of CYP3A4 within 28 days prior to dose of zibotentan.
- Use of phosphate binders (eg, aluminium hydroxide and calcium carbonate) and acid reducing agents such as cholestyramine/colestipol, ranitidine/nizatidine, or proton pump inhibitors within 3 days before and 12 hours after dosing with zibotentan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Zibotentan in Healthy Participants Compared to Participants With Moderate Hepatic and Moderate Renal Impairment
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of zibotentan in patients with moderate hepatic and moderate renal impairment in comparison to a matched healthy control group.
Read the detailed description
This is a single-dose, non-randomised, open-label, parallel-group study.
All participants will receive a single oral dose of 5 mg zibotentan under fasted conditions and will be involved in the study for approximately 5 weeks.
Approximately 12 participants will be enrolled into each one of the 2 cohorts and receive the study intervention:
- Cohort 1: 12 participants with moderate hepatic impairment and moderate renal impairment as assessed at Screening
- Cohort 2: 12 healthy participants matched for age (± 10 years), gender, and BMI (± 20%) on a group level to participants in Cohort 1
The study will comprise of the following study periods:
- A Screening Period of maximum 28 days (before dosing): participants will be screened for eligibility.
- A Residential Period of 8 days: participants will be admitted to the study centre in the evening on Day
- 2, two days before administration of a single oral dose of zibotentan (Day 1). Participants will have final study assessments on Day 6 (120 hours post-dose) and will be discharged that day.
- Conditions
- Hepatic Impairment, Renal Impairment
- Being tested
- Zibotentan
- Keywords
- Renal Impairment, Hepatic Impairment, Healthy participants, Zibotentan, Pharmacokinetics, Safety
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZibotentanDrug
All participants will receive a single oral dose of zibotentan capsule under fasted conditions.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Participants with moderate hepatic impairment and moderate renal impairment | Experimental | Participants will receive a single oral dose of zibotentan under fasted conditions. Receives: Drug: Zibotentan |
| Cohort 2: Healthy participants | Experimental | Participants will receive a single oral dose of zibotentan under fasted conditions. Receives: Drug: Zibotentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve from time zero to infinity (AUCinf)
To assess the PK of a single oral dose of zibotentan in participants with moderate hepatic impairment and moderate renal impairment compared to a group of healthy matched controls
Measured: Day 1 to Day 6
Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast)
To assess the PK of a single oral dose of zibotentan in participants with moderate hepatic impairment and moderate renal impairment compared to a group of healthy matched controls
Measured: Day 1 to Day 6
Maximum observed plasma concentration (Cmax)
To assess the PK of a single oral dose of zibotentan in participants with moderate hepatic impairment and moderate renal impairment compared to a group of healthy matched controls
Measured: Day 1 to Day 6
Secondary outcomes (14)
Number of participants with adverse events
To evaluate the safety and tolerability of a single oral dose of zibotentan in participants with moderate hepatic impairment and moderate renal impairment compared to a group of healthy matched controls
Measured: Screening (Day -28 to Day -2) to Day 6
Time to reach maximum observed plasma concentration (tmax)
To further characterise zibotentan plasma PK in all treatment groups
Measured: Day 1 to Day 6
Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC[0-24])
To further characterise zibotentan plasma PK in all treatment groups
Measured: Day 1 to Day 6
Area under plasma concentration-time curve from time zero to 72 hours post-dose (AUC [0-72])
To further characterise zibotentan plasma PK in all treatment groups
Measured: Day 1 to Day 6
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)
To further characterise zibotentan plasma PK in all treatment groups
Measured: Day 1 to Day 6
Terminal elimination rate constant (λz)
To further characterise zibotentan plasma PK in all treatment groups
Measured: Day 1 to Day 6
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
To further characterise zibotentan plasma PK in all treatment groups
Measured: Day 1 to Day 6
Apparent total non-renal body clearance of drug from plasma after extravascular administration (CLNR/F)
To further characterise zibotentan plasma PK in all treatment groups
Measured: Day 1 to Day 6
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
To further characterise zibotentan plasma PK in all treatment groups
Measured: Day 1 to Day 6
Amount of unchanged drug excreted into urine from time t1 to time t2 [Ae (t1-t2)]
To further characterise zibotentan urine PK in all treatment groups
Measured: Day 1 to Day 3
Cumulative amount of unchanged drug excreted into urine from time of dosing (time 0) through time t [Ae (0-t)]
To further characterise zibotentan urine PK in all treatment groups
Measured: Day 1 to Day 3
Percentage of dose excreted unchanged in urine from time t1 to time t2 [fe (t1-t2)]
To further characterise zibotentan urine PK in all treatment groups
Measured: Day 1 to Day 3
Percentage of dose excreted unchanged in urine from time of dosing (time 0) through time t [fe (0-t)]
To further characterise zibotentan urine PK in all treatment groups
Measured: Day 1 to Day 3
Renal clearance of drug from plasma, calculated as Ae0-t/AUC0-t where t is matched for urine and plasma (CLR)
To further characterise zibotentan urine PK in all treatment groups
Measured: Day 1 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start10 Nov 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two cohorts (patients and matched healthy subjects) to be enrolled for this study. Approximately 12 participants will be enrolled into each one of the 2 cohorts and receive the study intervention: * Cohort 1 will enroll participants with moderate hepatic impairment and moderate renal impairment as assessed at screening. * Cohort 2 will enroll healthy participants
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112419
- Sponsor's protocol ID
- D4326C00001
- Other IDs
- 2021-003289-10
- Status last verified
- Jan 2022
- First submitted
- 11 Oct 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Mercier AK, Sunnaker M, Ueckert S, Pawlik T, Henricson E, Molodetskyi O, Law GC, Parker VER, Oscarsson J. Pharmacokinetics and Tolerability of Zibotentan in Patients with Concurrent Moderate Renal and Moderate Hepatic Impairment. Clin Pharmacokinet. 2023 Dec;62(12):1713-1724. doi: 10.1007/s40262-023-01306-7. Epub 2023 Oct 6.
PubMed 37801266
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Zibotentan in Healthy Participants Compared to Participants With Moderate Hepatic and Moderate Renal Impairment
- ClinicalTrials.gov ID
- NCT05112419
- Acronym / sponsor ID
- D4326C00001
- Conditions
- Hepatic Impairment, Renal Impairment
- Keywords
- Renal Impairment, Hepatic Impairment, Healthy participants, Zibotentan, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 8 Nov 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.
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of zibotentan in patients with moderate hepatic and moderate renal impairment in comparison to a matched healthy control group.
Detailed description
This is a single-dose, non-randomised, open-label, parallel-group study.
All participants will receive a single oral dose of 5 mg zibotentan under fasted conditions and will be involved in the study for approximately 5 weeks.
Approximately 12 participants will be enrolled into each one of the 2 cohorts and receive the study intervention:
- Cohort 1: 12 participants with moderate hepatic impairment and moderate renal impairment as assessed at Screening
- Cohort 2: 12 healthy participants matched for age (± 10 years), gender, and BMI (± 20%) on a group level to participants in Cohort 1
The study will comprise of the following study periods:
- A Screening Period of maximum 28 days (before dosing): participants will be screened for eligibility.
- A Residential Period of 8 days: participants will be admitted to the study centre in the evening on Day
- 2, two days before administration of a single oral dose of zibotentan (Day 1). Participants will have final study assessments on Day 6 (120 hours post-dose) and will be discharged that day.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two cohorts (patients and matched healthy subjects) to be enrolled for this study. Approximately 12 participants will be enrolled into each one of the 2 cohorts and receive the study intervention: * Cohort 1 will enroll participants with moderate hepatic impairment and moderate renal impairment as assessed at screening. * Cohort 2 will enroll healthy participants
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Participants with moderate hepatic impairment and moderate renal impairment | Experimental | Drug: ZibotentanParticipants will receive a single oral dose of zibotentan under fasted conditions. |
| Cohort 2: Healthy participants | Experimental | Drug: ZibotentanParticipants will receive a single oral dose of zibotentan under fasted conditions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Body weight of at least 50 kg and body mass index within the range of 18 and 35 kg/m^2 (inclusive).
- Female of non-childbearing potential or male
- Participants with Moderate Hepatic Impairment and Moderate Renal Impairment only (Cohort 1)
- An estimated glomerular filtration rate (eGFR) in the range of 30 to 45 mL/min/1.73m^2 (inclusive) as determined using the Chronic Kidney Disease Epidemiology Collaboration formula, at Screening. Retesting for eGFR may be repeated twice during Screening Period.
- Confirmed clinical diagnosis of cirrhosis with either ascites or moderate hepatic impairment (Childs-Pugh B). Supporting documents confirming the participant's hepatic impairment must be available. The participant must be classified by the Investigator or usual practitioner as Child-Pugh Class B or having radiographic or clinical evidence of ascites of any grade.
Key exclusion criteria (24 listed)
- Medical Conditions
- Any evidence of a clinically significant disease which in the Investigator's opinion makes it undesirable for the participant to participate in the study.
- History of alcohol abuse or excessive intake of alcohol within 6 months prior to the Screening visit. Definition of excessive intake: an average weekly intake of >7 drinks/week for men or > 3.5 drinks/week for women. One drink is equivalent to (16 g of alcohol).
- Positive alcohol or drug of abuse at Screening.
- Participants with a history of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, to drugs with a similar chemical structure or class to zibotentan.
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 |
|---|---|---|
| ZibotentanAll participants will receive a single oral dose of zibotentan capsule under fasted conditions. | Drug | Cohort 1: Participants with moderate hepatic impairment and moderate renal impairment, Cohort 2: Healthy participants |
Primary outcome
Area under plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: Day 1 to Day 6
To assess the PK of a single oral dose of zibotentan in participants with moderate hepatic impairment and moderate renal impairment compared to a group of healthy matched controls
Area under the plasma concentration-curve from time zero to time of last quantifiable concentration (AUClast)
Time frame: Day 1 to Day 6
To assess the PK of a single oral dose of zibotentan in participants with moderate hepatic impairment and moderate renal impairment compared to a group of healthy matched controls
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 to Day 6
To assess the PK of a single oral dose of zibotentan in participants with moderate hepatic impairment and moderate renal impairment compared to a group of healthy matched controls
14 secondary outcomes
Number of participants with adverse events
Time frame: Screening (Day -28 to Day -2) to Day 6
Time to reach maximum observed plasma concentration (tmax)
Time frame: Day 1 to Day 6
Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC[0-24])
Time frame: Day 1 to Day 6
Area under plasma concentration-time curve from time zero to 72 hours post-dose (AUC [0-72])
Time frame: Day 1 to Day 6
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)
Time frame: Day 1 to Day 6
Terminal elimination rate constant (λz)
Time frame: Day 1 to Day 6
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Time frame: Day 1 to Day 6
Apparent total non-renal body clearance of drug from plasma after extravascular administration (CLNR/F)
Time frame: Day 1 to Day 6
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Time frame: Day 1 to Day 6
Amount of unchanged drug excreted into urine from time t1 to time t2 [Ae (t1-t2)]
Time frame: Day 1 to Day 3
Cumulative amount of unchanged drug excreted into urine from time of dosing (time 0) through time t [Ae (0-t)]
Time frame: Day 1 to Day 3
Percentage of dose excreted unchanged in urine from time t1 to time t2 [fe (t1-t2)]
Time frame: Day 1 to Day 3
Percentage of dose excreted unchanged in urine from time of dosing (time 0) through time t [fe (0-t)]
Time frame: Day 1 to Day 3
Renal clearance of drug from plasma, calculated as Ae0-t/AUC0-t where t is matched for urine and plasma (CLR)
Time frame: Day 1 to Day 3
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 27 Jan 2022.
- Derived from this study: PubMed 37801266Mercier AK, Sunnaker M, Ueckert S, Pawlik T, Henricson E, Molodetskyi O, Law GC, Parker VER, Oscarsson J. Pharmacokinetics and Tolerability of Zibotentan in Patients with Concurrent Moderate Renal and Moderate Hepatic Impairment. Clin Pharmacokinet. 2023 Dec;62(12):1713-1724. doi: 10.1007/s40262-023-01306-7. Epub 2023 Oct 6.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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 Zibotentan in people with Hepatic Impairment and Renal Impairment, run by AstraZeneca at 1 site in Bulgaria.
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 10 inclusion and 24 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 27 Jan 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 Bulgaria. 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?
Area under plasma concentration-time curve from time zero to infinity (AUCinf) (time frame: Day 1 to Day 6). The study lists 3 primary outcomes in all. 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 NCT05112419, which also lists 1 linked publication.
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 27 Jan 2022.