HealthyPhase 2NCT00359281
Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents
A Phase 2 study testing atorvastatin, simvastatin and ezetimibe in people with Healthy, run by Aegerion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This phase II, open-label research study was conducted in 129 healthy volunteers. Each subject will be given one initial oral dose of one of 7 FDA-approved medications (probe drugs), followed by a 7 day period where subjects receive the study medication AEGR-733 at 10 or 60 mg. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- atorvastatin, simvastatin and ezetimibe
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Nov 2007
- Phase
- Phase 2
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and non-pregnant/non-lactating female subjects between the ages of 18 and 70 who are in good overall health.
- To be eligible for enrollment in this study, patients must meet all of the following criteria:
- Men and women between the ages of 18 and 70
- Women of child-bearing potential, that is, women not surgically sterilized and between menarche and 1 year post menopause, must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of non-medication birth control (for example, a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy; or abstinence) during the study and for one month following the last dose of study drug.
- Subjects must be in good overall health
- Subjects must be able to comprehend and willing to provide a signed IRB approved Informed Consent Form.
- Subjects must be willing to comply with all study-related procedures.
Who cannot join
- Known atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
- History of diabetes mellitus or fasting glucose > 126 mg/dL at the screening visit.
- History of a non-skin malignancy within the previous 5 years
- Renal insufficiency as defined by creatinine > 1.3 mg/dl
- Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition
- History of hypertension
Show all 21Show fewer
- Known coagulopathy and /or elevated PT/PTT >1.5 x ULN
- Oral history of HIV positive
- Patients who have undergone any organ transplant
- Known active fibrotic or cirrhotic disease; ALT or AST > 1.5x ULN
- Any major surgery within the previous 3 months
- Individuals who currently use tobacco products or have done so in the previous 30 days
- History of drug abuse (< 3 years)
- Regular use of alcoholic beverages (> 7 drinks/day)
- Subjects who do not agree to abstain from consuming alcoholic beverages during the entire study duration.
- Body mass index (BMI) > 30 kg/m2 or < 18.5 kg/m2
- Participation in an investigational drug study within 6 weeks prior to the screening visit
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study will be excluded.
- Currently taking any prescription, including oral contraceptives, or OTC medication regularly that cannot be stopped for at least 30 days prior to enrollment until completion of the study
- Regular consumers of grapefruit juice, or have taken any medications known to be metabolized by CYP 3A4 within 4 weeks prior to the screening visit (ie. SSRIs, anti-fungals, anti-biotics, etc)
- History of myalgia with a statin or unknown hypersensitivity to any statin, zetia, AEGR-733, or fenofibrate.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II, Fixed-sequenced, Open- Label, Research Study to Assess Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Therapies in Healthy Volunteers
This phase II, open-label research study was conducted in 129 healthy volunteers. Each subject will be given one initial oral dose of one of 7 FDA-approved medications (probe drugs), followed by a 7 day period where subjects receive the study medication AEGR-733 at 10 or 60 mg. On study day 8 subjects will receive the second oral dose of the same probe drug that was given on day 1 and a last dose of AEGR-733 (total of 7 doses).Subjects will return in 1 week for a final safety visit. Each FDA- approved probe drug will be given to ten (10) or fifteen (15) subjects.
Safety, pharmacokinetic and pharmacodynamic assessments will be performed.
Read the detailed description
Objectives:
Primary: To evaluate the effects of low and high doses of AEGR-733 on the pharmacokinetics of 6 FDA-approved medications that are likely to be used in combination with AEGR-733 as assessed by:
- Pharmacokinetic parameters: Cmax, Tmax, T1/2, and AUC (area under the curve).
Secondary: To evaluate the safety of AEGR-733 in combination with other lipid lowering agents in healthy subject as assessed by:
- Changes in associated liver enzymes AST, ALT and, Alkaline Phosphatase, \& Total Bilirubin.
- Changes in all reported adverse events.
- To evaluate the effects of AEGR-733 in combination with other lipid lowering agents on the following lipids and lipoproteins: TC, LDL-C, VLDL, TG, HDL-C, ApoB and ApoAI.
4.0 STUDY DESIGN AND RATIONALE
4.1 STUDY DESIGN This is a single-center, phase II, clinical trial consisting of a eight (8) day open-label phase to assess the pharmacokinetic drug interactions of AEGR-733 on 6 probe drugs in healthy volunteers, followed by a one week safety visit. 105 subjects will be enrolled into this fixed-sequenced research study. Eligible subjects based on the screening visit will come to the GCRC for an inpatient visit (25-36 hr depending on if they come in evening before study day 1 or morning of). On the morning of study day 1, subjects will be assigned to one of 6 probe drugs(A-H below) and will take one dose of this medication. Timed blood samples will be drawn just before the administration of the probe drug and during the following times after drug administration (1,2,3,4,5,6,8,10,12,18, and 24 hrs). Prior to discharge after the 24 h blood sample, subjects will take an oral dose of AEGR-733 at 10 mg or 60 mg. Subjects will be given a 5 day supply of AEGR-733 at 10 mg or 60 mg to be taken once daily in the morning for the next 5 days (through day 7). On study day 8, subjects will take a final dose of AEGR-733 at 10 mg or 60 mg (total doses= 7) simultaneously with the same probe drug they took on day 1. Timed blood samples will be drawn just before the administration of the probe drug and AEGR-733 as well as 1,2,3,4,5,6,8,10,12,18, and 24 hours after study drug administration. After the 24 hour blood sample, subjects will be discharged. 15 subjects who participate in this study will receive dextromethorphan as the probe drug, which requires urine collection for 8 hours post dose. Blood for pharmacokinetic samples will not be collected on these subjects. Subjects receiving dextromethorphan may leave after the 8 hour urine collection at visits 2 and 3 (referred to as the inpatient visits). All subjects will come back 1 week later for a final visit to check safety lab parameters including liver transaminases and total bilirubin. Subjects will be instructed to abstain from drinking any alcoholic beverages once screened until study completion. Subjects who are not willing to comply with these requests will not be enrolled.
The FDA-approved lipid-lowering therapies will include:
- Atorvastatin, 20 mg (n=15)and AEGR-733 10 mg B) Ezetimibe, 10 mg (n=10)and AEGR-733 10 mg C) Simvastatin, 20 mg (n=15)and AEGR-733 10 mg D) Rosuvastatin, 20 mg (n=10)and AEGR-733 10 mg E) Micronized fenofibrate, 145 mg (n=10)and AEGR-733 10 mg F) Atorvastatin, 20 mg (n=15) and AEGR-733 60 mg G) Rosuvastatin, 20 mg (n=15) and AEGR-733 60 mg H) Dextromethorphan, 30 mg (n=15) and AEGR-733 60 mg I) Extended Release Niacin, 1000 mg (n=20) and AEGR-733 10 mg
- Conditions
- Healthy
- Being tested
- atorvastatin, simvastatin, ezetimibe, fenofibrate, dextromethorphan
- Keywords
- healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Atrovastatin 20 mg and AEGR-733 10 mg or 60 mg
simvastatinDrug
Simvastatin 20 mg and AEGR-733 10 mg or 60 mg
ezetimibeDrug
Ezetimibe 10 mg and AEGR-733 10 mg
fenofibrateDrug
Micronized Fenofibrate 145 mg and AEGR-733 10 mg
dextromethorphanDrug
Dextromethorphan 30 mg and AEGR-733 10 mg
Extended Release NiacinDrug
1000 mg ER niacin and AEGR-733 10 mg
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg)
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)
Measured: 0 to 24 hour
AUC0-t Simvastatin
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin
Measured: 0 to 24 hours
AUC0-t Simvastatin Acid
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin acid
Measured: 0 to 24 hours
AUC0-t Total Ezetimibe
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for total ezetimibe
Measured: 0 to 24 hours
AUC0-t Rosuvastatin (Lomitapide 10 mg)
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 10 mg)
Measured: 0 to 24 hours
AUC0-t Fenofibric Acid
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for fenofibric acid
Measured: 0 to 24 hours
AUC0-t Atorvastatin Acid (Lomitapide 60 mg)
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 60 mg)
Measured: 0 to 24 hours
AUC0-t Rosuvastatin (Lomitapide 60 mg)
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 60 mg)
Measured: 0 to 24 hours
AUC0-t Nicotinic Acid
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinic acid
Measured: 0 to 24 hours
AUC0-t Nicotinuric Acid
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinuric acid
Measured: 0 to 24 hours
Secondary outcomes (1)
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Percent change from Baseline in LDL-C
Measured: Baseline to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
- Study startMar 2006
- Primary completionNov 2007
- Study completionNov 2007
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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marina Cuchel, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359281
- Sponsor's protocol ID
- AEGR-733-002
- Other IDs
- Aegerion 002 PK study
- Status last verified
- Feb 2018
- First submitted
- 31 Jul 2006
- Last updated
- 23 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Fixed-sequenced, Open- Label, Research Study to Assess Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Therapies in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00359281
- Acronym / sponsor ID
- AEGR-733-002
- Conditions
- Healthy
- Keywords
- healthy volunteers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 2 Aug 2006 (estimated)
- Results
- Posted 4 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II, open-label research study was conducted in 129 healthy volunteers. Each subject will be given one initial oral dose of one of 7 FDA-approved medications (probe drugs), followed by a 7 day period where subjects receive the study medication AEGR-733 at 10 or 60 mg. On study day 8 subjects will receive the second oral dose of the same probe drug that was given on day 1 and a last dose of AEGR-733 (total of 7 doses).Subjects will return in 1 week for a final safety visit. Each FDA- approved probe drug will be given to ten (10) or fifteen (15) subjects.
Safety, pharmacokinetic and pharmacodynamic assessments will be performed.
Detailed description
Objectives:
Primary: To evaluate the effects of low and high doses of AEGR-733 on the pharmacokinetics of 6 FDA-approved medications that are likely to be used in combination with AEGR-733 as assessed by:
- Pharmacokinetic parameters: Cmax, Tmax, T1/2, and AUC (area under the curve).
Secondary: To evaluate the safety of AEGR-733 in combination with other lipid lowering agents in healthy subject as assessed by:
- Changes in associated liver enzymes AST, ALT and, Alkaline Phosphatase, \& Total Bilirubin.
- Changes in all reported adverse events.
- To evaluate the effects of AEGR-733 in combination with other lipid lowering agents on the following lipids and lipoproteins: TC, LDL-C, VLDL, TG, HDL-C, ApoB and ApoAI.
4.0 STUDY DESIGN AND RATIONALE
4.1 STUDY DESIGN This is a single-center, phase II, clinical trial consisting of a eight (8) day open-label phase to assess the pharmacokinetic drug interactions of AEGR-733 on 6 probe drugs in healthy volunteers, followed by a one week safety visit. 105 subjects will be enrolled into this fixed-sequenced research study. Eligible subjects based on the screening visit will come to the GCRC for an inpatient visit (25-36 hr depending on if they come in evening before study day 1 or morning of). On the morning of study day 1, subjects will be assigned to one of 6 probe drugs(A-H below) and will take one dose of this medication. Timed blood samples will be drawn just before the administration of the probe drug and during the following times after drug administration (1,2,3,4,5,6,8,10,12,18, and 24 hrs). Prior to discharge after the 24 h blood sample, subjects will take an oral dose of AEGR-733 at 10 mg or 60 mg. Subjects will be given a 5 day supply of AEGR-733 at 10 mg or 60 mg to be taken once daily in the morning for the next 5 days (through day 7). On study day 8, subjects will take a final dose of AEGR-733 at 10 mg or 60 mg (total doses= 7) simultaneously with the same probe drug they took on day 1. Timed blood samples will be drawn just before the administration of the probe drug and AEGR-733 as well as 1,2,3,4,5,6,8,10,12,18, and 24 hours after study drug administration. After the 24 hour blood sample, subjects will be discharged. 15 subjects who participate in this study will receive dextromethorphan as the probe drug, which requires urine collection for 8 hours post dose. Blood for pharmacokinetic samples will not be collected on these subjects. Subjects receiving dextromethorphan may leave after the 8 hour urine collection at visits 2 and 3 (referred to as the inpatient visits). All subjects will come back 1 week later for a final visit to check safety lab parameters including liver transaminases and total bilirubin. Subjects will be instructed to abstain from drinking any alcoholic beverages once screened until study completion. Subjects who are not willing to comply with these requests will not be enrolled.
The FDA-approved lipid-lowering therapies will include:
- Atorvastatin, 20 mg (n=15)and AEGR-733 10 mg B) Ezetimibe, 10 mg (n=10)and AEGR-733 10 mg C) Simvastatin, 20 mg (n=15)and AEGR-733 10 mg D) Rosuvastatin, 20 mg (n=10)and AEGR-733 10 mg E) Micronized fenofibrate, 145 mg (n=10)and AEGR-733 10 mg F) Atorvastatin, 20 mg (n=15) and AEGR-733 60 mg G) Rosuvastatin, 20 mg (n=15) and AEGR-733 60 mg H) Dextromethorphan, 30 mg (n=15) and AEGR-733 60 mg I) Extended Release Niacin, 1000 mg (n=20) and AEGR-733 10 mg
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and non-pregnant/non-lactating female subjects between the ages of 18 and 70 who are in good overall health.
- To be eligible for enrollment in this study, patients must meet all of the following criteria:
- Men and women between the ages of 18 and 70
- Women of child-bearing potential, that is, women not surgically sterilized and between menarche and 1 year post menopause, must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of non-medication birth control (for example, a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy; or abstinence) during the study and for one month following the last dose of study drug.
- Subjects must be in good overall health
Key exclusion criteria (21 listed)
- Known atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
- History of diabetes mellitus or fasting glucose > 126 mg/dL at the screening visit.
- History of a non-skin malignancy within the previous 5 years
- Renal insufficiency as defined by creatinine > 1.3 mg/dl
- Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition
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 |
|---|---|---|
| atorvastatinAtrovastatin 20 mg and AEGR-733 10 mg or 60 mg | Drug | – |
| simvastatinSimvastatin 20 mg and AEGR-733 10 mg or 60 mg | Drug | – |
| ezetimibeEzetimibe 10 mg and AEGR-733 10 mg | Drug | – |
| fenofibrateMicronized Fenofibrate 145 mg and AEGR-733 10 mg | Drug | – |
| dextromethorphanDextromethorphan 30 mg and AEGR-733 10 mg | Drug | – |
| Extended Release Niacin1000 mg ER niacin and AEGR-733 10 mg | Drug | – |
Primary outcome
Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg)
Time frame: 0 to 24 hour
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 10 mg)
AUC0-t Simvastatin
Time frame: 0 to 24 hours
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin
AUC0-t Simvastatin Acid
Time frame: 0 to 24 hours
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for simvastatin acid
AUC0-t Total Ezetimibe
Time frame: 0 to 24 hours
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for total ezetimibe
AUC0-t Rosuvastatin (Lomitapide 10 mg)
Time frame: 0 to 24 hours
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 10 mg)
AUC0-t Fenofibric Acid
Time frame: 0 to 24 hours
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for fenofibric acid
AUC0-t Atorvastatin Acid (Lomitapide 60 mg)
Time frame: 0 to 24 hours
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for atorvastatin acid (Lomitapide 60 mg)
AUC0-t Rosuvastatin (Lomitapide 60 mg)
Time frame: 0 to 24 hours
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for rosuvastatin (Lomitapide 60 mg)
AUC0-t Nicotinic Acid
Time frame: 0 to 24 hours
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinic acid
AUC0-t Nicotinuric Acid
Time frame: 0 to 24 hours
Geometric Mean Ratio ln(AUC0-t) Day 8/Day 1 for nicotinuric acid
1 secondary outcome
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline to Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marina Cuchel, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing atorvastatin, simvastatin and ezetimibe in people with Healthy, run by Aegerion Pharmaceuticals, Inc. 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 7 inclusion and 21 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 23 Feb 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Mar 2014). 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?
Area Under Concentration-time Curve From 0 to Last Measureable Concentration (AUC0-t) Atorvastatin Acid (Lomitapide 10 mg) (time frame: 0 to 24 hour). The study lists 10 primary outcomes in all. 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 23 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.