Pharmacology, ClinicalPhase 1DDINCT01707407
A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
A Phase 1 study testing Pomalidomide, Ketoconazole and Fluvoxamine in people with Pharmacology, Clinical and Healthy, run by Celgene at 1 site in United States.
Trial summary
1. To evaluate the pharmacokinetics (PK) of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide alone in healthy male subjects. 2. To evaluate the PK of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole plus the CYP1A2 inhibitor fluvoxamine compared with… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacology, Clinical, Healthy
- What is being tested?
- Pomalidomide, Ketoconazole and Fluvoxamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2012to 1 Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must understand and voluntarily sign a written informed consent document (ICD) prior to any study-related procedures being performed.
- Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- Must be a male 18 to 55 years of age (inclusive) at the time of signing the ICD, with a body mass index (BMI = weight [kg]/(height [m2]) between 18 and 33 kg/m2 (inclusive) and weight between 60 and 100 kg (132 to 220 lbs; inclusive)
- For Part 1, subjects may be of any race.
- For Part 2, subjects must be non-Asian or non-Asian descent.
- Must be healthy (at Screening and Day -1 of Period 1) as determined by the investigator on the basis of medical history, physical examination, clinical laboratory safety test results, vital signs, and 12 lead electrocardiograms (ECGs).
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- Vital signs (systolic and diastolic blood pressure, pulse rate, and oral body temperature) will be assessed in the supine position after the subject has rested for at least 5 minutes.
- Subject must be afebrile (febrile is defined as ≥ 38.5ºC or 101.3 Fahrenheit).
- Systolic blood pressure in the range of 90 to 140 mmHg, diastolic blood pressure in the range of 60 to 90 mmHg, and pulse rate in the range of 45 to 100 bpm.
- Must have a normal or clinically acceptable 12-lead ECG, with a QTcF value ≤ 430 msec.
- Clinical laboratory safety tests must be within normal limits or clinically acceptable to the Principal investigator (PI)
- Subjects (with or without vasectomy) must agree to use barrier contraception (ie, latex condom or any non-latex condom not made out of natural [animal] membrane [eg, polyurethane]) and one other method (eg, spermicide) when engaging in sexual activity with woman of child-bearing potential during study conduct, and for 90 days after the last dose of study medication.
- Must agree to refrain from donating blood or plasma (other than for this study) while participating in this study and for at least 28 days after the last dose of study drug.
- Similarly, must agree to refrain from donating sperm while participating in this study and for at least 90 days after the last dose of study drug.
- Will be counseled about pregnancy precautions and risks of fetal exposure and agree to comply with the conditions described in the counseling document.
Who cannot join
- History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, known hypersensitivity to a member of the class of-IMIDs (immune-mediated inflammatory diseases), or other major disorders
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study.
- Any condition that confounds the ability to interpret data from the study.
- Used any prescribed systemic or topical medication within 30 days of the first dose administration, unless Sponsor agreement is obtained.
- Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration, unless Sponsor agreement is obtained.
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- Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME), eg, bariatric procedure.
- Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
- History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual within 2 years before dosing, or positive drug screening test reflecting consumption of illicit drugs.
- History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing, or positive alcohol screen.
- Known to have, or tests positive for, active or chronic hepatitis B, hepatitis C, or HIV antibodies.
- Exposed to an investigational drug (new chemical entity) within 60 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
- Received vaccination (excluding seasonal flu vaccination) within 90 days of the study drug administration.
- Smokes more than 10 cigarettes, or consumes the equivalent in tobacco, per day.
- Subjects who are part of the staff personnel or family members of the investigational study staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Research Unit, Inc
Madison, Wisconsin, 53704
About this study
- To evaluate the pharmacokinetics (PK) of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide alone in healthy male subjects.
- To evaluate the PK of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole plus the CYP1A2 inhibitor fluvoxamine compared with pomalidomide alone in healthy male subjects.
- To assess the PK of pomalidomide administered with the CYP1A2 inhibitor fluvoxamine and the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide plus the CYP3A4/P-gp inhibitor ketoconazole in healthy male subjects.
Part 2
Read more
- To evaluate the pharmacokinetics of pomalidomide administered with the CYP3A4 inducer carbamazepine compared with pomalidomide alone in healthy male volunteers.
Secondary Objectives
- To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered with ketoconazole, fluvoxamine and/or carbamazepine.
In addition: To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered with ketoconazole, fluvoxamine and/or carbamazepine.
Read the detailed description
This will be a single-center, open label non randomized, 2-part study with 3 periods in Part 1, and 2 periods in Part 2. Parts 1 and 2 will be conducted in parallel. The entire study will consist of a screening phase, two dosing parts, and a follow-up telephone call for safety. All Periods will be separated by a washout period of at least 3 days (no more than 5 days) from the last pomalidomide dose to the next drug dose.
Safety will be monitored throughout the study. Safety evaluations will include adverse event (AE) reporting, concomitant medications, PEs, vital sign measurements, 12-lead ECGs, and clinical laboratory safety tests.
Thirty-two healthy (16 per each Part), male adult subjects 18 to 55 years of age who meet all inclusion criteria and do not meet any of the exclusion criteria will be enrolled in the study. Subjects enrolled in Part 1 cannot participate in Part 2 and vice versa.
Study treatments (pomalidomide, ketoconazole, fluvoxamine and carbamazepine) should be administered with meals and subjects should be a served a standard meal (ie, breakfast or dinner) approximately 30 minutes prior to dosing. The meal should be consumed within 30 minutes from serving and dosing must occur 30 minutes (±5 minutes) after serving the meal. Subjects should be encouraged to consume the whole meal served prior to dosing. After each dosing, food and beverages (except water) will be withheld from all subjects until at least 4 hours post dose; thereafter, subjects will be served standard meals and snacks.
For determination of plasma concentrations of pomalidomide, ketoconazole, fluvoxamine and carbamazepine (and its active metabolite carbamazepine 10,11-epoxide) in each dosing regimen (Period), serial blood samples will be collected.
A safety follow-up will be conducted by telephone within 4 to 7 days from the last dose. In the event a subject discontinues from the study prematurely, an early termination visit will be performed within 4 days following the day of discontinuation.
- Conditions
- Pharmacology, Clinical, Healthy
- Being tested
- Pomalidomide, Ketoconazole, Fluvoxamine, Carbamazepine
- Keywords
- CC-4047, Pomalidomide, Ketoconazole, Fluvoxamine, Carbamazepine, DDI, safety, tolerability, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
Also called (CC-4047)
4 mg pomalidomide capsule administered orally once in the morning
KetoconazoleDrug
200 mg Ketoconazole tablet administered orally twice a day on Days 1-7.
FluvoxamineDrug
50 mg Fluvoxamine tablet administered orally twice a day on Days 1-7.
CarbamazepineDrug
100 mg Carbamazepine tablet administered orally once in the evening on Day 1
100 mg Carbamazepine tablet administered orally twice daily on Days 2-3
200 mg Carbamazepine tablet administered orally twice daily on Days 4-11
| Study group | Role | What they receive |
|---|---|---|
| Pomalidomide | Experimental | Not described Receives: Drug: Pomalidomide |
| Pomalidomide plus Ketoconazole | Experimental | Not described Receives: Drug: Pomalidomide; Drug: Ketoconazole |
| Pomalidomide plus Ketoconazole plus Fluvoxamine | Experimental | Not described Receives: Drug: Pomalidomide; Drug: Ketoconazole; Drug: Fluvoxamine |
| Pomalidomide plus Carbamazepine | Experimental | Not described Receives: Drug: Pomalidomide; Drug: Carbamazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK-Cmax
Cmax-Maximum observed concentration in plasma
Measured: Up to 13 days
PK-Tmax
Tmax: Time to maximum concentration
Measured: Up to 13 days
PK-AUC
AUC-Area under the plasma concentration-time curve
Measured: Up to 13 days
PK-(T1/2)
T1/2-Terminal half-life
Measured: Up to 13 days
PK-CL/F
CL/F-Apparent total plasma clearance
Measured: Up to 13 days
PK-Vz/F
Vz/F: Apparent total volume of distribution
Measured: Up to 13 days
Secondary outcomes (1)
Adverse Events
Number of participants with adverse events
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study start1 Sep 2012
- Primary completion1 Nov 2012
- Study completion1 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pharmacology, ClinicalStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Palmisano, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707407
- Sponsor's protocol ID
- CC-4047-CP-008
- Acronym
- DDI
- Status last verified
- Nov 2019
- First submitted
- 12 Oct 2012
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Tun HW, Johnston PB, DeAngelis LM, Atherton PJ, Pederson LD, Koenig PA, Reeder CB, Omuro AMP, Schiff D, O'Neill B, Pulido J, Jaeckle KA, Grommes C, Witzig TE. Phase 1 study of pomalidomide and dexamethasone for relapsed/refractory primary CNS or vitreoretinal lymphoma. Blood. 2018 Nov 22;132(21):2240-2248. doi: 10.1182/blood-2018-02-835496. Epub 2018 Sep 27.
PubMed 30262659Mark TM, Forsberg PA, Rossi AC, Pearse RN, Pekle KA, Perry A, Boyer A, Tegnestam L, Jayabalan D, Coleman M, Niesvizky R. Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. Blood Adv. 2019 Feb 26;3(4):603-611. doi: 10.1182/bloodadvances.2018028027.
PubMed 30792190
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01707407
- Acronym / sponsor ID
- DDI / CC-4047-CP-008
- Conditions
- Pharmacology, Clinical, Healthy
- Keywords
- CC-4047, Pomalidomide, Ketoconazole, Fluvoxamine, Carbamazepine, DDI, safety, tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 1 Nov 2012 (actual)
- Study completion
- 1 Nov 2012 (actual)
- First posted
- 16 Oct 2012 (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.
- To evaluate the pharmacokinetics (PK) of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide alone in healthy male subjects.
- To evaluate the PK of pomalidomide administered with the CYP3A4/P-gp inhibitor ketoconazole plus the CYP1A2 inhibitor fluvoxamine compared with pomalidomide alone in healthy male subjects.
- To assess the PK of pomalidomide administered with the CYP1A2 inhibitor fluvoxamine and the CYP3A4/P-gp inhibitor ketoconazole compared with pomalidomide plus the CYP3A4/P-gp inhibitor ketoconazole in healthy male subjects.
Part 2
- To evaluate the pharmacokinetics of pomalidomide administered with the CYP3A4 inducer carbamazepine compared with pomalidomide alone in healthy male volunteers.
Secondary Objectives
- To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered with ketoconazole, fluvoxamine and/or carbamazepine.
In addition: To evaluate the safety of pomalidomide in Part 1 and Part 2 when administered with ketoconazole, fluvoxamine and/or carbamazepine.
Detailed description
This will be a single-center, open label non randomized, 2-part study with 3 periods in Part 1, and 2 periods in Part 2. Parts 1 and 2 will be conducted in parallel. The entire study will consist of a screening phase, two dosing parts, and a follow-up telephone call for safety. All Periods will be separated by a washout period of at least 3 days (no more than 5 days) from the last pomalidomide dose to the next drug dose.
Safety will be monitored throughout the study. Safety evaluations will include adverse event (AE) reporting, concomitant medications, PEs, vital sign measurements, 12-lead ECGs, and clinical laboratory safety tests.
Thirty-two healthy (16 per each Part), male adult subjects 18 to 55 years of age who meet all inclusion criteria and do not meet any of the exclusion criteria will be enrolled in the study. Subjects enrolled in Part 1 cannot participate in Part 2 and vice versa.
Study treatments (pomalidomide, ketoconazole, fluvoxamine and carbamazepine) should be administered with meals and subjects should be a served a standard meal (ie, breakfast or dinner) approximately 30 minutes prior to dosing. The meal should be consumed within 30 minutes from serving and dosing must occur 30 minutes (±5 minutes) after serving the meal. Subjects should be encouraged to consume the whole meal served prior to dosing. After each dosing, food and beverages (except water) will be withheld from all subjects until at least 4 hours post dose; thereafter, subjects will be served standard meals and snacks.
For determination of plasma concentrations of pomalidomide, ketoconazole, fluvoxamine and carbamazepine (and its active metabolite carbamazepine 10,11-epoxide) in each dosing regimen (Period), serial blood samples will be collected.
A safety follow-up will be conducted by telephone within 4 to 7 days from the last dose. In the event a subject discontinues from the study prematurely, an early termination visit will be performed within 4 days following the day of discontinuation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide | Experimental | Drug: Pomalidomide |
| Pomalidomide plus Ketoconazole | Experimental | Drug: Pomalidomide, Drug: Ketoconazole |
| Pomalidomide plus Ketoconazole plus Fluvoxamine | Experimental | Drug: Pomalidomide, Drug: Ketoconazole, Drug: Fluvoxamine |
| Pomalidomide plus Carbamazepine | Experimental | Drug: Pomalidomide, Drug: Carbamazepine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Must understand and voluntarily sign a written informed consent document (ICD) prior to any study-related procedures being performed.
- Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- Must be a male 18 to 55 years of age (inclusive) at the time of signing the ICD, with a body mass index (BMI = weight [kg]/(height [m2]) between 18 and 33 kg/m2 (inclusive) and weight between 60 and 100 kg (132 to 220 lbs; inclusive)
- Must be healthy (at Screening and Day -1 of Period 1) as determined by the investigator on the basis of medical history, physical examination, clinical laboratory safety test results, vital signs, and 12 lead electrocardiograms (ECGs).
- Subjects (with or without vasectomy) must agree to use barrier contraception (ie, latex condom or any non-latex condom not made out of natural [animal] membrane [eg, polyurethane]) and one other method (eg, spermicide) when engaging in sexual activity with woman of child-bearing potential during study conduct, and for 90 days after the last dose of study medication.
Key exclusion criteria (15 listed)
- History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, known hypersensitivity to a member of the class of-IMIDs (immune-mediated inflammatory diseases), or other major disorders
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study.
- Any condition that confounds the ability to interpret data from the study.
- Used any prescribed systemic or topical medication within 30 days of the first dose administration, unless Sponsor agreement is obtained.
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 |
|---|---|---|
| PomalidomideAlso: (CC-4047)4 mg pomalidomide capsule administered orally once in the morning | Drug | Pomalidomide, Pomalidomide plus Carbamazepine, Pomalidomide plus Ketoconazole, Pomalidomide plus Ketoconazole plus Fluvoxamine |
| Ketoconazole200 mg Ketoconazole tablet administered orally twice a day on Days 1-7. | Drug | Pomalidomide plus Ketoconazole, Pomalidomide plus Ketoconazole plus Fluvoxamine |
| Fluvoxamine50 mg Fluvoxamine tablet administered orally twice a day on Days 1-7. | Drug | Pomalidomide plus Ketoconazole plus Fluvoxamine |
| Carbamazepine100 mg Carbamazepine tablet administered orally once in the evening on Day 1 100 mg Carbamazepine tablet administered orally twice daily on Days 2-3 200 mg Carbamazepine tablet administered orally twice daily on Days 4-11 | Drug | Pomalidomide plus Carbamazepine |
Primary outcome
PK-Cmax
Time frame: Up to 13 days
Cmax-Maximum observed concentration in plasma
PK-Tmax
Time frame: Up to 13 days
Tmax: Time to maximum concentration
PK-AUC
Time frame: Up to 13 days
AUC-Area under the plasma concentration-time curve
PK-(T1/2)
Time frame: Up to 13 days
T1/2-Terminal half-life
PK-CL/F
Time frame: Up to 13 days
CL/F-Apparent total plasma clearance
PK-Vz/F
Time frame: Up to 13 days
Vz/F: Apparent total volume of distribution
1 secondary outcome
Adverse Events
Time frame: Up to 15 days
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 12 Nov 2019.
- Background: PubMed 30262659Tun HW, Johnston PB, DeAngelis LM, Atherton PJ, Pederson LD, Koenig PA, Reeder CB, Omuro AMP, Schiff D, O'Neill B, Pulido J, Jaeckle KA, Grommes C, Witzig TE. Phase 1 study of pomalidomide and dexamethasone for relapsed/refractory primary CNS or vitreoretinal lymphoma. Blood. 2018 Nov 22;132(21):2240-2248. doi: 10.1182/blood-2018-02-835496. Epub 2018 Sep 27.
- Background: PubMed 30792190Mark TM, Forsberg PA, Rossi AC, Pearse RN, Pekle KA, Perry A, Boyer A, Tegnestam L, Jayabalan D, Coleman M, Niesvizky R. Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. Blood Adv. 2019 Feb 26;3(4):603-611. doi: 10.1182/bloodadvances.2018028027.
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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.
Maria Palmisano, MD study director
Celgene Corporation
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 Pomalidomide, Ketoconazole and Fluvoxamine in people with Pharmacology, Clinical and Healthy, run by Celgene 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 15 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 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK-Cmax (time frame: Up to 13 days). The study lists 6 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 NCT01707407, which also lists 2 linked publications.
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 12 Nov 2019.