Healthy SubjectsPhase 1NCT02243657
A Study to Assess the Safety, Tolerability, and Effects in and on the Body of Healthy Young and Elderly Male and Female Subjects of Ascending Multiple Oral Doses of ASP3652
A Phase 1 study testing ASP3652 in people with Healthy Subjects and Pharmacokinetics of ASP3652, run by Astellas Pharma Europe B.V. at 1 site in Netherlands.
Trial summary
The study investigates how safe ASP3652 is and how well it is tolerated when taken as multiple doses. The study also assesses how quickly and to what extent it is absorbed and eliminated from the body. In addition, the effects of age and gender are investigated. The study consists of two parts. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Pharmacokinetics of ASP3652, Pharmacodynamics of ASP3652
- What is being tested?
- ASP3652
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2009to May 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) between 18.5-30.0 kg/m2 for both male and female subjects.
- Male subject is non-fertile, i.e. surgically sterilized or practices an adequate contraceptive method to prevent pregnancies.
- Female subject is of non-child bearing potential, i.e. post menopausal, surgically sterilized, hysterectomy in medical history, or practices adequate (double barrier) non-hormonal contraceptive method to prevent pregnancies.
Who cannot join
- Pregnant or breast feeding within 6 months before screening assessment.
- Presence or history of any clinically significant psychiatric disorder such as mania, depression or schizophrenia.
- Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Multiple Oral Doses of ASP3652 in Healthy Young and Elderly Male and Female Subjects
The study investigates how safe ASP3652 is and how well it is tolerated when taken as multiple doses. The study also assesses how quickly and to what extent it is absorbed and eliminated from the body. In addition, the effects of age and gender are investigated.
The study consists of two parts. In Part 1 four dose levels are administered to four separate groups initially. Two additional dosages are then investigated. Subjects receive either a once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo.
Read more
Part 2 is performed in one group of elderly healthy male or female (post-menopausal) subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo.
For both parts of the study, the subjects stay in the clinic for one period of 18 days.
Read the detailed description
This is a Multiple Ascending Dose (MAD) study with two parts. Screening for both parts takes place between Days -28 and -3. Subjects are admitted to the clinic on Day -2, and discharged on Day 16. They return for an End of Study Visit (ESV) between 7 and 14 days after (early) discharge.
Part 1 evaluates the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ASP3652 following ascending multiple oral doses. The initially planned four dose levels or matching placebo are given to four separate groups. Thereafter two additional dosage levels are further investigated. All groups receive a single dose of ASP3652 administered in the morning of Day 1 and Day 14, and twice-daily doses administered from Day 2 to Day 13 under fasted conditions, except the last group which receives all dosages once daily from Day 1 to Day 14.
Part 2 evaluates the safety, tolerability, PK and PD of ASP3652 following ascending multiple oral doses in healthy elderly male and female subjects. This part contains a single, placebo-controlled group. All subjects receive twice daily doses and administration is based on the results of Part 1.
All subjects in both parts receive training for Neurocognitive Test Battery (NTB) and tests for monitoring of psychotropic effects.
- Being tested
- ASP3652, Placebo
- Keywords
- ASP3652, Age, Gender, Pharmacokinetics, Pharmacodynamics, Phase 1, Multiple Ascending Doses (MAD)
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP3652Drug
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1: Placebo dose level | Placebo comparator | Not described Receives: Drug: Placebo |
| 2: ASP3652 lowest dose level twice daily | Experimental | Not described Receives: Drug: ASP3652 |
| 3:ASP3652 low dose level twice daily | Experimental | Not described Receives: Drug: ASP3652 |
| 4: ASP3652 medium dose level twice daily | Experimental | Not described Receives: Drug: ASP3652 |
| 5: ASP3652 high dose level twice daily | Experimental | Not described Receives: Drug: ASP3652 |
| 6: ASP3652 highest dose level once daily | Experimental | Not described Receives: Drug: ASP3652 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature, frequency and severity of adverse events
Measured: Screening to 14 days after discharge
Physical examination and vital signs
Measured: Screening to 14 days after discharge
Body temperature
Measured: Screening to 14 days after discharge
Routine safety laboratory tests
Measured: Screening to 14 days after discharge
12 -lead Electrocardiogram (ECG)
Measured: Screening to 14 days after discharge
Holter ECG
Measured: Day -1 and Day14
Monitoring of psychotropic / cannabinoids-like effects
Measured: Screening to 14 days after discharge
Neurocognition Test Battery (NTB)
Measured: Screening to 14 days after discharge
Examination for skin lesions
Measured: Screening to 14 days after discharge
Pharmacokinetic (PK) profile in plasma for first dose measured by area under the plasma concentration - time curve from time zero to infinity (AUCinf)
Measured: Day 1 to Day 2
PK profile in plasma for first dose measured by area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast)
Measured: Day 1 to Day 2
PK profile in plasma for first dose measured by maximum plasma concentration (Cmax)
Measured: Day 1 to Day 2
PK profile in plasma for first dose measured by time to attain Cmax (tmax)
Measured: Day 1 to Day 2
PK profile in plasma for first dose measured by elimination half-life (t½)
Measured: Day 1 to Day 2
PK profile in plasma for first dose measured by absorption lag time (tlag)
Measured: Day 1 to Day 2
PK profile in plasma for first dose measured by apparent volume of distribution during the terminal phase (Vz/F)
Measured: Day 1 to Day 2
PK profile in plasma for first dose measured by apparent total clearance of the drug from plasma after oral administration (CL/F)
Measured: Day 1 to Day 2
PK profile in urine for first dose measured by cumulative amount of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast)
Measured: Day 1 to Day 2
PK profile in urine for first dose measured by cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf)
Measured: Day 1 to Day 2
PK profile in urine for first dose measured by percentage of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast%)
Measured: Day 1 to Day 2
PK profile in urine for first dose measured by percentage of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf%)
Measured: Day 1 to Day 2
PK profile in urine for first dose measured by renal clearance of the drug from plasma (CLR)
Measured: Day 1 to Day 2
PK profile in plasma for last dose measured by area under the plasma concentration - time curve between consecutive dosing (AUCtau)
Only for Bis in die (twice daily) (BID) dosing
Measured: Day 14 to Day 16
PK profile in plasma for last dose measured by area under the plasma concentration- time curve from the time of dosing up to 24 hours (AUC0-24)
Only for BID dosing
Measured: Day 14 to Day 16
PK profile in plasma for last dose measured by tmax
Measured: Day 14 to Day 16
PK profile in plasma for last dose measured by Cmax
Measured: Day 14 to Day 16
PK profile in plasma for last dose measured by t½
Measured: Day 14 to Day 16
PK profile in plasma for last dose measured by Vz/F
Measured: Day 14 to Day 16
PK profile in plasma for last dose measured by CL/F
Measured: Day 14 to Day 16
PK profile in plasma for last dose measured by accumulation ratio (Rac)
Measured: Day 14 to Day 16
PK profile in plasma for last dose measured by Peak Trough Ratio (PTR)
Measured: Day 14 to Day 16
PK profile in plasma for last dose measured by plasma concentration at the end of a dosing interval at steady state (Ctrough)
Measured: Day 14 to Day 16
PK profile in urine for last dose measured by cumulative amount of drug excreted into urine over the time interval between consecutive dosing (Aetau)
Only for BID dosing
Measured: Day 14 to Day 16
PK profile in urine for last dose measured by fraction of the drug excreted into urine (Aetau) over the time interval between consecutive dosing (Aetau%)
Only for BID dosing
Measured: Day 14 to Day 16
PK profile in urine for last dose measured by CLR
Only for BID dosing
Measured: Day 14 to Day 16
PK profile in urine for last dose measured by cumulative amount of unchanged drug excreted into the urine from 0 to 24 hours (Ae0-24)
Only for BID dosing
Measured: Day 14 to Day 16
PK profile in urine for last dose measured by percentage of unchanged drug excreted into the urine from 0 to 24 hours (Ae0-24%)
Measured: Day 14 to Day 16
Secondary outcomes (5)
Assessment of Pharmacodynamics measured by Ex vivo enzyme activity in mononuclear cells
Measured: Day -1 to Day 16
Pharmacodynamics measured by levels of arachidonoyl-ethanolamide (AEA) in plasma and seminal fluid (exploratory)
Measured: Day -2 or -1 and day 11, 12 or 13
Pharmacodynamics measured by levels of oleoyl-ethanolamide (OEA) in plasma and seminal fluid (exploratory)
Measured: Day -2 or -1 and day 11, 12 or 13
Pharmacodynamics measured by levels of palmitoyl-ethanolamide (PEA) in plasma and seminal fluid (exploratory)
Measured: Day -2 or -1 and day 11, 12 or 13
Assessment of Pharmacodynamics measured by intraocular pressure (IOP) (exploratory)
Measured: Day -1 to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243657
- Sponsor's protocol ID
- 3652-CL-0002
- Other IDs
- 2008-006416-38, 2008
- Status last verified
- Sep 2014
- First submitted
- 19 Aug 2014
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Multiple Oral Doses of ASP3652 in Healthy Young and Elderly Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02243657
- Acronym / sponsor ID
- 3652-CL-0002
- Keywords
- ASP3652, Age, Gender, Pharmacokinetics, Pharmacodynamics, Phase 1, Multiple Ascending Doses (MAD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 18 Sep 2014 (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.
The study investigates how safe ASP3652 is and how well it is tolerated when taken as multiple doses. The study also assesses how quickly and to what extent it is absorbed and eliminated from the body. In addition, the effects of age and gender are investigated.
The study consists of two parts. In Part 1 four dose levels are administered to four separate groups initially. Two additional dosages are then investigated. Subjects receive either a once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo.
Part 2 is performed in one group of elderly healthy male or female (post-menopausal) subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo.
For both parts of the study, the subjects stay in the clinic for one period of 18 days.
Detailed description
This is a Multiple Ascending Dose (MAD) study with two parts. Screening for both parts takes place between Days -28 and -3. Subjects are admitted to the clinic on Day -2, and discharged on Day 16. They return for an End of Study Visit (ESV) between 7 and 14 days after (early) discharge.
Part 1 evaluates the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ASP3652 following ascending multiple oral doses. The initially planned four dose levels or matching placebo are given to four separate groups. Thereafter two additional dosage levels are further investigated. All groups receive a single dose of ASP3652 administered in the morning of Day 1 and Day 14, and twice-daily doses administered from Day 2 to Day 13 under fasted conditions, except the last group which receives all dosages once daily from Day 1 to Day 14.
Part 2 evaluates the safety, tolerability, PK and PD of ASP3652 following ascending multiple oral doses in healthy elderly male and female subjects. This part contains a single, placebo-controlled group. All subjects receive twice daily doses and administration is based on the results of Part 1.
All subjects in both parts receive training for Neurocognitive Test Battery (NTB) and tests for monitoring of psychotropic effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1: Placebo dose level | Placebo comparator | Drug: Placebo |
| 2: ASP3652 lowest dose level twice daily | Experimental | Drug: ASP3652 |
| 3:ASP3652 low dose level twice daily | Experimental | Drug: ASP3652 |
| 4: ASP3652 medium dose level twice daily | Experimental | Drug: ASP3652 |
| 5: ASP3652 high dose level twice daily | Experimental | Drug: ASP3652 |
| 6: ASP3652 highest dose level once daily | Experimental | Drug: ASP3652 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) between 18.5-30.0 kg/m2 for both male and female subjects.
- Male subject is non-fertile, i.e. surgically sterilized or practices an adequate contraceptive method to prevent pregnancies.
- Female subject is of non-child bearing potential, i.e. post menopausal, surgically sterilized, hysterectomy in medical history, or practices adequate (double barrier) non-hormonal contraceptive method to prevent pregnancies.
Key exclusion criteria (3 listed)
- Pregnant or breast feeding within 6 months before screening assessment.
- Presence or history of any clinically significant psychiatric disorder such as mania, depression or schizophrenia.
- Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
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 |
|---|---|---|
| ASP3652oral | Drug | 2: ASP3652 lowest dose level twice daily, 3:ASP3652 low dose level twice daily, 4: ASP3652 medium dose level twice daily, 5: ASP3652 high dose level twice daily, 6: ASP3652 highest dose level once daily |
| Placebooral | Drug | 1: Placebo dose level |
Primary outcome
Nature, frequency and severity of adverse events
Time frame: Screening to 14 days after discharge
Physical examination and vital signs
Time frame: Screening to 14 days after discharge
Body temperature
Time frame: Screening to 14 days after discharge
Routine safety laboratory tests
Time frame: Screening to 14 days after discharge
12 -lead Electrocardiogram (ECG)
Time frame: Screening to 14 days after discharge
Holter ECG
Time frame: Day -1 and Day14
Monitoring of psychotropic / cannabinoids-like effects
Time frame: Screening to 14 days after discharge
Neurocognition Test Battery (NTB)
Time frame: Screening to 14 days after discharge
Examination for skin lesions
Time frame: Screening to 14 days after discharge
Pharmacokinetic (PK) profile in plasma for first dose measured by area under the plasma concentration - time curve from time zero to infinity (AUCinf)
Time frame: Day 1 to Day 2
PK profile in plasma for first dose measured by area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast)
Time frame: Day 1 to Day 2
PK profile in plasma for first dose measured by maximum plasma concentration (Cmax)
Time frame: Day 1 to Day 2
PK profile in plasma for first dose measured by time to attain Cmax (tmax)
Time frame: Day 1 to Day 2
PK profile in plasma for first dose measured by elimination half-life (t½)
Time frame: Day 1 to Day 2
PK profile in plasma for first dose measured by absorption lag time (tlag)
Time frame: Day 1 to Day 2
PK profile in plasma for first dose measured by apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Day 1 to Day 2
PK profile in plasma for first dose measured by apparent total clearance of the drug from plasma after oral administration (CL/F)
Time frame: Day 1 to Day 2
PK profile in urine for first dose measured by cumulative amount of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast)
Time frame: Day 1 to Day 2
PK profile in urine for first dose measured by cumulative amount of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf)
Time frame: Day 1 to Day 2
PK profile in urine for first dose measured by percentage of unchanged drug excreted into the urine from time zero to time of last measurable concentration (Aelast%)
Time frame: Day 1 to Day 2
PK profile in urine for first dose measured by percentage of unchanged drug excreted into the urine from time zero to infinity after single dose (Aeinf%)
Time frame: Day 1 to Day 2
PK profile in urine for first dose measured by renal clearance of the drug from plasma (CLR)
Time frame: Day 1 to Day 2
PK profile in plasma for last dose measured by area under the plasma concentration - time curve between consecutive dosing (AUCtau)
Time frame: Day 14 to Day 16
Only for Bis in die (twice daily) (BID) dosing
PK profile in plasma for last dose measured by area under the plasma concentration- time curve from the time of dosing up to 24 hours (AUC0-24)
Time frame: Day 14 to Day 16
Only for BID dosing
PK profile in plasma for last dose measured by tmax
Time frame: Day 14 to Day 16
PK profile in plasma for last dose measured by Cmax
Time frame: Day 14 to Day 16
PK profile in plasma for last dose measured by t½
Time frame: Day 14 to Day 16
PK profile in plasma for last dose measured by Vz/F
Time frame: Day 14 to Day 16
PK profile in plasma for last dose measured by CL/F
Time frame: Day 14 to Day 16
PK profile in plasma for last dose measured by accumulation ratio (Rac)
Time frame: Day 14 to Day 16
PK profile in plasma for last dose measured by Peak Trough Ratio (PTR)
Time frame: Day 14 to Day 16
PK profile in plasma for last dose measured by plasma concentration at the end of a dosing interval at steady state (Ctrough)
Time frame: Day 14 to Day 16
PK profile in urine for last dose measured by cumulative amount of drug excreted into urine over the time interval between consecutive dosing (Aetau)
Time frame: Day 14 to Day 16
Only for BID dosing
PK profile in urine for last dose measured by fraction of the drug excreted into urine (Aetau) over the time interval between consecutive dosing (Aetau%)
Time frame: Day 14 to Day 16
Only for BID dosing
PK profile in urine for last dose measured by CLR
Time frame: Day 14 to Day 16
Only for BID dosing
PK profile in urine for last dose measured by cumulative amount of unchanged drug excreted into the urine from 0 to 24 hours (Ae0-24)
Time frame: Day 14 to Day 16
Only for BID dosing
PK profile in urine for last dose measured by percentage of unchanged drug excreted into the urine from 0 to 24 hours (Ae0-24%)
Time frame: Day 14 to Day 16
5 secondary outcomes
Assessment of Pharmacodynamics measured by Ex vivo enzyme activity in mononuclear cells
Time frame: Day -1 to Day 16
Pharmacodynamics measured by levels of arachidonoyl-ethanolamide (AEA) in plasma and seminal fluid (exploratory)
Time frame: Day -2 or -1 and day 11, 12 or 13
Pharmacodynamics measured by levels of oleoyl-ethanolamide (OEA) in plasma and seminal fluid (exploratory)
Time frame: Day -2 or -1 and day 11, 12 or 13
Pharmacodynamics measured by levels of palmitoyl-ethanolamide (PEA) in plasma and seminal fluid (exploratory)
Time frame: Day -2 or -1 and day 11, 12 or 13
Assessment of Pharmacodynamics measured by intraocular pressure (IOP) (exploratory)
Time frame: Day -1 to Day 15
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 18 Sep 2014.
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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.
Central Contact study chair
Astellas Pharma Europe B.V.
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 ASP3652 in people with Healthy Subjects and Pharmacokinetics of ASP3652, run by Astellas Pharma Europe B.V. at 1 site in Netherlands.
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 3 inclusion and 3 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 18 Sep 2014. 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 Netherlands. 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?
Nature, frequency and severity of adverse events (time frame: Screening to 14 days after discharge). The study lists 37 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 18 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.