Drug OverdosePhase 1/2OPI-14-001NCT02307721
Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use
A Phase 1/2 study testing Intranasal naloxone, Intramuscular naloxone and Remifentanil in people with Drug Overdose, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, higher than road traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Overdose
- What is being tested?
- Intranasal naloxone, Intramuscular naloxone and Remifentanil
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2014to Sep 2015
- Phase
- Phase 1/2
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class I
- ECG without pathologic abnormalities
- BMI range of 18,5 - 24,9 kg/m2.
- lab values within reference values at St Olav's Hospital for the relevant haematological and biochemical test for inclusion:
- Haemoglobin (male: 13.4-17.0 g/dL, female 11.7 - 15.3 g/dL)
- Creatinine (male: 60-105 micromole/L, female 45 - 90 micromole/L)
Show all 11Show fewer
- Aspartate aminotransferases (ASAT) (male: 15-45 U/L, female: 15-35 U/L)
- Alanine transaminase (ALAT) (male: 10-70 U/L, female: 10-45 U/L)
- Gamma glutamyl transpeptidase (GT) (male: 10-80 U/L, female: 10-45 U/L)
- For women in reproductive age: serum HCG (normal under 3 ye/L)
- Signed informed consent and expected cooperation of the subjects for the treatment
Who cannot join
- Taking any medications including herbal medicines the last week prior to treatment visits
- Current or history of drug and/or alcohol abuse (To assess problematic drug or alcohol use we use the CAGE AID screening tool)
- History of contact with police or authorities in relation to alcohol or drug offences
- History of prolonged use of opioid analgesics
- History of prior drug allergy
- Having any local nasal disease or nasal surgery for the last 2 months or recent cold for the last week
Show all 12Show fewer
- Pregnant women (HCG over 3 ye/L at inclusion)
- Women in reproductive age not using high efficacy contraceptives (Oral contraceptives, Patch (Evra), Implants, Vaginal ring, Hormonal IUD, Copper intra-uterine device (IUD), Sterilization) throughout the study period until their last visit.
- Breastfeeding women
- Participants with access to remifentanil or other potent opioids in their daily workplace.
- Hypersensitivity to naloxone or remifentanil hydrochloride and/or to any of its excipients.
- Any reason why, in the opinion of the investigator, the patient should not participate.
Trial locations and contacts
1 site in 1 country.
About this study
Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, higher than road traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose (intranasal) has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. In a series of studies on intranasal naloxone at The Norwegian University of Science and Technology, this study explores pharmacokinetics and pharmacodynamics of intranasal and intramuscular naloxone in healthy volunteers under the influence of remifentanil.
Read the detailed description
Healthy volunteers will be brought into a state of opioid influence in a well-known, short acting, controlled and safe manner using remifentanil.
Naloxone is a well-known, well-tolerated drug with an excellent safety profile over many decades of use. The current formulation has proven safe and without local or systemic side effects in the studies conducted so far. The excipients in the present nasal formulation are all well known.
This study has two aims. Firstly to investigate what naloxone does to the body under opioid influence, applying a well-tested model with infusion of the potent opioid remifentanil (Target Control Infusion). This will create a state of strong opioid effect for a short time and in a highly controlled fashion, inducing a state of miosis, reduced respiratory rate and reduced sensation to pain, all three strong indicators of opiates. Naloxone will antagonise these effects, and this change can be measured. Choosing intramuscular 0.8 mg naloxone for comparison means that the novel intranasal naloxone formulation will be compared with the well-established and described treatment protocol for opioid overdose in Norway used today.
Secondly the pharmacokinetic profile of intranasal and intramuscular naloxone will be studied. The same measurements as in preparative studies (OPI 12-001 and OPI 13-001) will be taken: Serum naloxone concentration over time to calculate maximum concentration, Time to maximum concentration, Area Under the Curve and Relative bioavailability. There are two main reasons to repeat these measurements. In contrast to the previous studies under the current protocol the participants will be under the influence by strong opioids. This may have significant physiologic effects, and it will be explored whether the pharmacokinetics of the intranasal formulation are changed. The other reason is that in this study pharmacokinetics of naloxone will be compared with the actual dosage and administration routes of naloxone as used by doctors and paramedics in the pre-hospital setting. This has not been done before, in spite of the widespread use of this treatment, The measurements of remifentanil in serum open the possibility to relate pharmacodynamic data directly to an actual serum concentration of the opioid at the same time.
Care will be taken not to include opioid users in this study as naloxone would precipitate acute withdrawal. Also possible drug misusers will be excluded as well as people who have access to remifentanil and infusion equipment in their daily work, although the abuse potential of this highly specialised drug is minimal.
Safety of the formulation will also be studied by measuring vital signs and for the patient to report any nasal discomfort or potential adverse reactions during the study.
By weighing spray device, and intramuscular syringes before and after discharge the reliability of the dose delivered will be confirmed.
- Conditions
- Drug Overdose
- Being tested
- Intranasal naloxone, Intramuscular naloxone, Remifentanil, Aptar Unidose
- Keywords
- Emergency Treatment, Morphine Derivates, Heroin, Antidotes, Administration, Intranasal, Pharmacology, Naloxone, Healthy volunteers
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal naloxoneDrug
Administer 0,1 ml 8 mg/ml naloxone intranasally, dose = 0,8 mg naloxone
Intramuscular naloxoneDrug
Also called Naloxone B Braun 0,4 mg/ml
Administer 2 mL, dose intramuscular naloxone 0,8 mg
RemifentanilDrug
Administer remifentanil intravenously by way of Target Control Infusion, Minto model at a target of 2,5 ng/ml. This to achieve a state of safe and predictable opioid influence to assess pharmacodynamic response to naloxone. After treatment of 4 participants protocol amended 22. january 2015 to reduce remifentanil target to 1,25 ng/ml in the next 4. In the last 4 participants the dose will be decided later, but not exceed 2,5 ng/ml.
Aptar UnidoseDevice
This is the spray device chosen, and its function in this setting (spray up side down) will be assessed by weighing the device before and after administration.
| Study group | Role | What they receive |
|---|---|---|
| intranasal naloxone | Experimental | 8 mg/ml naloxone 0,1 mL IN as one puff in one nostril in supine position Receives: Drug: Intranasal naloxone; Drug: Remifentanil; Device: Aptar Unidose |
| Intramuscular naloxone | Active comparator | 0,4 mg/ml Naloxone B Braun 2 ML in deltoid muscle Receives: Drug: Intramuscular naloxone; Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic profile of naloxone- Heat Pain Threshold
We will measure time to maximum reversal, and duration of reversal of opioid effect on heat pain threshold measured. Heat pain thresholds will be tested using a Somedic MSA Thermotest (Somedic AB, Hørby, Sweden). This apparatus can measure the relationship between the intensity of controlled thermal stimuli and the associated perception. The stimulus (1 degree Celsius per sec rise time) is applied to the intact skin by a hand-held thermode while monitoring the temperature. The thermode (area 25x 50 mm= 12,5 cm2) will be placed over the non-dominant thenar eminence. Once the sensation changes from warm to painful the subject stops the increase in temperature by pressing a button, and the thermode cools down. The heat pain threshold (HPT) is measured in degrees C, and we will calculate the average of three repeated single HPTs.
Measured: 120 minutes
Pharmacodynamic profile of naloxone. Pupillometry
Using a Neuroptics VIP 200 Pupillometer (Neuroptics, Irvine, CA, USA) we will measure the size of the pupils as a pharmacodynamic measure. The treatment visits will be conducted in a quiet room, with moderate, stable ambient lighting. Using a luxometer we will ensure similar light conditions in each visit of each participant. We will ask the participant to focus on a distant point in the room. The pupillometer will be placed over the measured eye and its position adjusted until the eye was correctly aligned within the LCD screen of the pupillometer. The reading will be recorded in CRF and/ or local work sheet A measurement of the pupils should take less than 10 seconds, and the result is given in millimetre, with an accuracy of 0.1mm and the results recorded. It is a non-invasive and pain free measurement.
Measured: 120 minutes
Secondary outcomes (6)
Adverse Events
will be reported from the start of the first session to the follow-up visit.
Measured: minimum 6 days
Quantitate serum concentrations of remifentanil at specified time points
Measure serum concentration of remifentanil by Gas Chromatography-Mass Spectrometry (GCMS) at 0,15,30,45, 60 and 90 minutes.
Measured: 110 minutes
Suitability of spray device in prehospital setting
By weighting spray device before and after intranasal administration to asses function in the supine patient.
Measured: 100 minutes
Pharmacokinetics: Area Under the Curve of IN and IM naloxone
Measurement of serum naloxone at times 2,5,10,15,20,25,30,35,45,60,90,120,240 and 360 minutes after naloxone administration
Measured: 360 minutes
Pharmacokinetics: maximum concentration (Cmax) of IN and IM naloxone
Measurement of serum naloxone at times 2, 5, 10, 15, 20, 25, 30, 35, 45, 60, 90, 120, 240 and 360 minutes after naloxone administration
Measured: 360 minutes
Pharmacokinetics: time to maximum concentration (Tmax) of IN and IM naloxone
Measurement of serum naloxone at times 2, 5, 10, 15, 20, 25, 30, 35, 45, 60, 90, 120, 240 and 360 minutes after naloxone administration
Measured: 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionSep 2015
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 Drug OverdoseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Toril A Nagelhus Hernes, phd prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307721
- Sponsor's protocol ID
- OPI-14-001
- Other IDs
- 2014-001465-27, 2014
- Acronym
- OPI-14-001
- Status last verified
- Oct 2018
- First submitted
- 23 Nov 2014
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Skulberg AK, Tylleskar I, Nilsen T, Skarra S, Salvesen O, Sand T, Loftsson T, Dale O. Pharmacokinetics and -dynamics of intramuscular and intranasal naloxone: an explorative study in healthy volunteers. Eur J Clin Pharmacol. 2018 Jul;74(7):873-883. doi: 10.1007/s00228-018-2443-3. Epub 2018 Mar 22.
PubMed 29568976
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use
- ClinicalTrials.gov ID
- NCT02307721
- Acronym / sponsor ID
- OPI-14-001 / OPI-14-001
- Conditions
- Drug Overdose
- Keywords
- Emergency Treatment, Morphine Derivates, Heroin, Antidotes, Administration, Intranasal, Pharmacology, Naloxone, Healthy volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Dec 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Dec 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.
Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, higher than road traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose (intranasal) has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. In a series of studies on intranasal naloxone at The Norwegian University of Science and Technology, this study explores pharmacokinetics and pharmacodynamics of intranasal and intramuscular naloxone in healthy volunteers under the influence of remifentanil.
Detailed description
Healthy volunteers will be brought into a state of opioid influence in a well-known, short acting, controlled and safe manner using remifentanil.
Naloxone is a well-known, well-tolerated drug with an excellent safety profile over many decades of use. The current formulation has proven safe and without local or systemic side effects in the studies conducted so far. The excipients in the present nasal formulation are all well known.
This study has two aims. Firstly to investigate what naloxone does to the body under opioid influence, applying a well-tested model with infusion of the potent opioid remifentanil (Target Control Infusion). This will create a state of strong opioid effect for a short time and in a highly controlled fashion, inducing a state of miosis, reduced respiratory rate and reduced sensation to pain, all three strong indicators of opiates. Naloxone will antagonise these effects, and this change can be measured. Choosing intramuscular 0.8 mg naloxone for comparison means that the novel intranasal naloxone formulation will be compared with the well-established and described treatment protocol for opioid overdose in Norway used today.
Secondly the pharmacokinetic profile of intranasal and intramuscular naloxone will be studied. The same measurements as in preparative studies (OPI 12-001 and OPI 13-001) will be taken: Serum naloxone concentration over time to calculate maximum concentration, Time to maximum concentration, Area Under the Curve and Relative bioavailability. There are two main reasons to repeat these measurements. In contrast to the previous studies under the current protocol the participants will be under the influence by strong opioids. This may have significant physiologic effects, and it will be explored whether the pharmacokinetics of the intranasal formulation are changed. The other reason is that in this study pharmacokinetics of naloxone will be compared with the actual dosage and administration routes of naloxone as used by doctors and paramedics in the pre-hospital setting. This has not been done before, in spite of the widespread use of this treatment, The measurements of remifentanil in serum open the possibility to relate pharmacodynamic data directly to an actual serum concentration of the opioid at the same time.
Care will be taken not to include opioid users in this study as naloxone would precipitate acute withdrawal. Also possible drug misusers will be excluded as well as people who have access to remifentanil and infusion equipment in their daily work, although the abuse potential of this highly specialised drug is minimal.
Safety of the formulation will also be studied by measuring vital signs and for the patient to report any nasal discomfort or potential adverse reactions during the study.
By weighing spray device, and intramuscular syringes before and after discharge the reliability of the dose delivered will be confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intranasal naloxone | Experimental | Drug: Intranasal naloxone, Drug: Remifentanil, Device: Aptar Unidose8 mg/ml naloxone 0,1 mL IN as one puff in one nostril in supine position |
| Intramuscular naloxone | Active comparator | Drug: Intramuscular naloxone, Drug: Remifentanil0,4 mg/ml Naloxone B Braun 2 ML in deltoid muscle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- American Society of Anesthesiologists (ASA) class I
- ECG without pathologic abnormalities
- BMI range of 18,5 - 24,9 kg/m2.
- lab values within reference values at St Olav's Hospital for the relevant haematological and biochemical test for inclusion:
- Signed informed consent and expected cooperation of the subjects for the treatment
Key exclusion criteria (12 listed)
- Taking any medications including herbal medicines the last week prior to treatment visits
- Current or history of drug and/or alcohol abuse (To assess problematic drug or alcohol use we use the CAGE AID screening tool)
- History of contact with police or authorities in relation to alcohol or drug offences
- History of prolonged use of opioid analgesics
- History of prior drug allergy
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 |
|---|---|---|
| Intranasal naloxoneAdminister 0,1 ml 8 mg/ml naloxone intranasally, dose = 0,8 mg naloxone | Drug | intranasal naloxone |
| Intramuscular naloxoneAlso: Naloxone B Braun 0,4 mg/mlAdminister 2 mL, dose intramuscular naloxone 0,8 mg | Drug | Intramuscular naloxone |
| RemifentanilAdminister remifentanil intravenously by way of Target Control Infusion, Minto model at a target of 2,5 ng/ml. This to achieve a state of safe and predictable opioid influence to assess pharmacodynamic response to naloxone. After treatment of 4 participants protocol amended 22. january 2015 to reduce remifentanil target to 1,25 ng/ml in the next 4. In the last 4 participants the dose will be decided later, but not exceed 2,5 ng/ml. | Drug | Intramuscular naloxone, intranasal naloxone |
| Aptar UnidoseThis is the spray device chosen, and its function in this setting (spray up side down) will be assessed by weighing the device before and after administration. | Device | intranasal naloxone |
Primary outcome
Pharmacodynamic profile of naloxone- Heat Pain Threshold
Time frame: 120 minutes
We will measure time to maximum reversal, and duration of reversal of opioid effect on heat pain threshold measured. Heat pain thresholds will be tested using a Somedic MSA Thermotest (Somedic AB, Hørby, Sweden). This apparatus can measure the relationship between the intensity of controlled thermal stimuli and the associated perception. The stimulus (1 degree Celsius per sec rise time) is applied to the intact skin by a hand-held thermode while monitoring the temperature. The thermode (area 25x 50 mm= 12,5 cm2) will be placed over the non-dominant thenar eminence. Once the sensation changes from warm to painful the subject stops the increase in temperature by pressing a button, and the thermode cools down. The heat pain threshold (HPT) is measured in degrees C, and we will calculate the average of three repeated single HPTs.
Pharmacodynamic profile of naloxone. Pupillometry
Time frame: 120 minutes
Using a Neuroptics VIP 200 Pupillometer (Neuroptics, Irvine, CA, USA) we will measure the size of the pupils as a pharmacodynamic measure. The treatment visits will be conducted in a quiet room, with moderate, stable ambient lighting. Using a luxometer we will ensure similar light conditions in each visit of each participant. We will ask the participant to focus on a distant point in the room. The pupillometer will be placed over the measured eye and its position adjusted until the eye was correctly aligned within the LCD screen of the pupillometer. The reading will be recorded in CRF and/ or local work sheet A measurement of the pupils should take less than 10 seconds, and the result is given in millimetre, with an accuracy of 0.1mm and the results recorded. It is a non-invasive and pain free measurement.
6 secondary outcomes
Adverse Events
Time frame: minimum 6 days
Quantitate serum concentrations of remifentanil at specified time points
Time frame: 110 minutes
Suitability of spray device in prehospital setting
Time frame: 100 minutes
Pharmacokinetics: Area Under the Curve of IN and IM naloxone
Time frame: 360 minutes
Pharmacokinetics: maximum concentration (Cmax) of IN and IM naloxone
Time frame: 360 minutes
Pharmacokinetics: time to maximum concentration (Tmax) of IN and IM naloxone
Time frame: 360 minutes
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 17 Oct 2018.
- Results publication: PubMed 29568976Skulberg AK, Tylleskar I, Nilsen T, Skarra S, Salvesen O, Sand T, Loftsson T, Dale O. Pharmacokinetics and -dynamics of intramuscular and intranasal naloxone: an explorative study in healthy volunteers. Eur J Clin Pharmacol. 2018 Jul;74(7):873-883. doi: 10.1007/s00228-018-2443-3. Epub 2018 Mar 22.
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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.
Toril A Nagelhus Hernes, phd prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intranasal naloxone, Intramuscular naloxone and Remifentanil in people with Drug Overdose, run by Norwegian University of Science and Technology at 1 site in Norway.
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 11 inclusion and 12 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 17 Oct 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 Norway. 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 combined 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.
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?
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?
Pharmacodynamic profile of naloxone- Heat Pain Threshold (time frame: 120 minutes). The study lists 2 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 NCT02307721, 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 17 Oct 2018.