Healthy ParticipantsPhase 1NCT01372085
Single Dose Study in Healthy Participants to Investigate the Safety and Absorption of LY2584702
A Phase 1 study testing LY2584702 Reference Formulation and LY2584702 Test Formulation in people with Healthy Participants, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
This is a single-centre, placebo-controlled, two-part study in healthy participants. Part A will be a single dose, single period, placebo-controlled pilot study to explore the safety, tolerability, absorption and pharmacodynamic [effect of drug on a biological marker-phospho-S6 (pS6) levels in skin biopsies] of a… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- LY2584702 Reference Formulation and LY2584702 Test Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2011to Sep 2011
- Phase
- Phase 1
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male participants:
- Agree to use a reliable method of birth control during the study and for at least 1 month following the last dose of study drug
- Female participants:
- Women not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to 45 years old, who have not taken hormones or oral contraceptives within the last year, and had cessation of menses for at least 1 year, or who have had 6 to 12 months of amenorrhea with follicle-stimulating hormone (FSH) levels consistent with postmenopausal state.
- All participants:
- have a screening body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2), inclusive
Show all 11Show fewer
- have clinical laboratory test results within the normal range for the population or investigator site, or with abnormalities deemed clinically insignificant by the investigator. In particular, participants should have normal or near normal screening liver tests at the discretion of the investigator
- have normal blood pressure and pulse rate (supine) at screening, or with minor deviations judged to be acceptable by the investigator
- have venous access sufficient to allow blood sampling as per the protocol
- are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
Who cannot join
- All participants:
- are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Participants that participate in Part A of this study may participate in Part B of the study if the first dosing in Part B is >30 days after the dose of LY2584702 or placebo in Part A.
- have known allergies to LY2584702, or related compounds
- have an abnormality in the 12-lead electrocardiogram (ECG) [including but not limited to Bazett's corrected QT (QTcB) interval >450 milliseconds (msec) for men and >470 msec for women]
- have a history within the last 2 years or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- have a history of drug or alcohol abuse, or regularly use known drugs of abuse
Show all 14Show fewer
- show evidence of human immunodeficiency virus infection and/or positive human immunodeficiency virus (HIV) antibodies
- show evidence of hepatitis B and/or positive hepatitis B surface antigen
- intend to use over-the-counter or prescription medication within 14 days prior to dosing or during the study
- use of herbal supplements, grapefruit juice, grapefruits, Seville orange juice, Seville oranges, or Starfruit within 7 days prior to study dosing or intended use during the study
- have donated blood of more than 450 milliliters (mL) within the last 3 months
- have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to stop alcohol consumption from prior to dosing until the completion of each study period [ unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
- Applicable for Part A only:
- have known allergies to lignocaine, adrenaline, tetracycline, or related compounds, which will be used in the skin biopsy procedure
Trial locations and contacts
1 site in 1 country.
Singapore1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Singapore
About this study
Official title: A Single Ascending Dose and Relative Bioavailability Study of LY2584702 in Healthy Subjects
This is a single-centre, placebo-controlled, two-part study in healthy participants.
Part A will be a single dose, single period, placebo-controlled pilot study to explore the safety, tolerability, absorption and pharmacodynamic [effect of drug on a biological marker-phospho-S6 (pS6) levels in skin biopsies] of a single dose of 25 milligrams (mg) LY2584702 Reference formulation (RF). Part B is a single dose, placebo-controlled, 4-period crossover study to primarily evaluate the absorption of the Test Formulation (TF) in comparison with the (RF) of LY2584702.
- Conditions
- Healthy Participants
- Being tested
- LY2584702 Reference Formulation, LY2584702 Test Formulation, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2584702 Reference FormulationDrug
Administered orally
LY2584702 Test FormulationDrug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part A: 25 mg RF | Experimental | A single 25 mg dose of LY2584702 RF Receives: Drug: LY2584702 Reference Formulation |
| Part A: Placebo | Placebo comparator | Placebo taken orally Receives: Drug: Placebo |
| Part B: Sequence 1 | Experimental | A single 10 mg dose of LY2584702 TF during the first intervention period, followed by placebo in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. Receives: Drug: LY2584702 Test Formulation; Drug: Placebo |
| Part B: Sequence 2 | Experimental | Placebo during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. Receives: Drug: LY2584702 Reference Formulation; Drug: LY2584702 Test Formulation; Drug: Placebo |
| Part B: Sequence 3 | Experimental | A single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. Receives: Drug: LY2584702 Reference Formulation; Drug: LY2584702 Test Formulation; Drug: Placebo |
| Part B: Sequence 4 | Experimental | A single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by placebo in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. Receives: Drug: LY2584702 Reference Formulation; Drug: LY2584702 Test Formulation; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)
The Cmax following a single oral dose of LY2584702 test formulation [TF (tablet)] or reference formulation [RF (capsule)] is reported.
Measured: Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose]
Secondary outcomes (4)
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC)
AUC from time 0 to the time of the last quantifiable concentration [AUC(0-tlast)] and AUC from time 0 to infinity [AUC(0-inf)] following a single oral dose of LY2584702 test formulation [TF (tablet)] or reference formulation [RF (capsule)] is reported.
Measured: Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose]
Part B: Baseline-Adjusted Change-From-Predose in the Concentration of Lipids (Total Cholesterol)
Baseline-adjusted change-from-predose in lipid concentrations were measured to assess the LY2584702 effect on lipids under different fed states. The 50-milligram (mg) LY2584702 test formulation [TF (tablet)] was the only dose and formulation administered in both the fasted and fed states for comparison. Therefore, changes in total cholesterol after single oral doses of placebo, 10-mg, or 200-mg LY2584702 TF or 25-mg or 50-mg LY2584702 reference formulation [RF (capsule)] were not calculated. The baseline-adjusted change-from-predose in total cholesterol levels in the fasted and fed state following a single 50-mg LY2584702 TF dose is reported. Baseline was Day -1 of Period 1 for Period 3 fasted state and baseline was Day -1 of Period 4a for Period 4a fed state. Least squares (LS) means was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, time, treatment by time, and participant.
Measured: Part B: Baseline [Periods 1 and 4a (Day -1)], Periods 3, 4a (Day 1). Lipid concentration measurements were performed at time point 0 and 1 hour (h), 3 h, 4 h, 6 h, 10 h, and 24 h.
Part A: QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using Fridericia's formula: QTcF = QT/RR^0.33. The QTcF after single oral doses of LY2584702 reference formulation [RF (capsule)] were administered in a fasted state are reported at baseline (Day 1, Predose) and 3 hours (h), 4 h, 6 h, and 24 h postdose.
Measured: Part A: Baseline [Day 1 (Predose)] and Day 1 (3 h, 4 h, 6 h, and 24 h postdose)
Part B: Average Time-Matched QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using Fridericia's formula: QTcF = QT/RR^0.33. The QTcF after single oral doses of LY2584702 test formulation [TF (tablet)], LY2584702 reference formulation [RF (capsule)], or placebo were administered in a fasted or fed state are reported at baseline (time-matched Day -1 QTcF) and 3 hours (h), 4 h, 6 h, and 24 h postdose. Day 1, Hour 24 was time-matched with Day-1, Hour 0.
Measured: Part B: Baseline [Period 1 (Day -1)] and Periods 1 to 4 (Day 1). Electrocardiograms (ECG) were performed at time point 0 and 3 h, 4 h, 6 h, and 24 h.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
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 Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372085
- Sponsor's protocol ID
- 14318
- Other IDs
- I3G-FW-JGCE
- Status last verified
- Aug 2018
- First submitted
- 2 Jun 2011
- Last updated
- 22 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose and Relative Bioavailability Study of LY2584702 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01372085
- Acronym / sponsor ID
- 14318
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Posted 22 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-centre, placebo-controlled, two-part study in healthy participants.
Part A will be a single dose, single period, placebo-controlled pilot study to explore the safety, tolerability, absorption and pharmacodynamic [effect of drug on a biological marker-phospho-S6 (pS6) levels in skin biopsies] of a single dose of 25 milligrams (mg) LY2584702 Reference formulation (RF). Part B is a single dose, placebo-controlled, 4-period crossover study to primarily evaluate the absorption of the Test Formulation (TF) in comparison with the (RF) of LY2584702.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: 25 mg RF | Experimental | Drug: LY2584702 Reference FormulationA single 25 mg dose of LY2584702 RF |
| Part A: Placebo | Placebo comparator | Drug: PlaceboPlacebo taken orally |
| Part B: Sequence 1 | Experimental | Drug: LY2584702 Test Formulation, Drug: PlaceboA single 10 mg dose of LY2584702 TF during the first intervention period, followed by placebo in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
| Part B: Sequence 2 | Experimental | Drug: LY2584702 Reference Formulation, Drug: LY2584702 Test Formulation, Drug: PlaceboPlacebo during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
| Part B: Sequence 3 | Experimental | Drug: LY2584702 Reference Formulation, Drug: LY2584702 Test Formulation, Drug: PlaceboA single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by a single dose of 50 mg TF in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
| Part B: Sequence 4 | Experimental | Drug: LY2584702 Reference Formulation, Drug: LY2584702 Test Formulation, Drug: PlaceboA single 10 mg dose of LY2584702 TF during the first intervention period, followed by a single dose of 50 mg RF in the second intervention period, followed by placebo in the third intervention period, followed by either an open-label single dose of 50 mg TF after a high fat breakfast (Period 4a) OR placebo or escalated dose of TF in the fasted state (Period 4b). There will be a washout period of at least 3 days between periods. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Agree to use a reliable method of birth control during the study and for at least 1 month following the last dose of study drug
- Women not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to 45 years old, who have not taken hormones or oral contraceptives within the last year, and had cessation of menses for at least 1 year, or who have had 6 to 12 months of amenorrhea with follicle-stimulating hormone (FSH) levels consistent with postmenopausal state.
- have a screening body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2), inclusive
- have clinical laboratory test results within the normal range for the population or investigator site, or with abnormalities deemed clinically insignificant by the investigator. In particular, participants should have normal or near normal screening liver tests at the discretion of the investigator
- have normal blood pressure and pulse rate (supine) at screening, or with minor deviations judged to be acceptable by the investigator
Key exclusion criteria (14 listed)
- are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Participants that participate in Part A of this study may participate in Part B of the study if the first dosing in Part B is >30 days after the dose of LY2584702 or placebo in Part A.
- have known allergies to LY2584702, or related compounds
- have an abnormality in the 12-lead electrocardiogram (ECG) [including but not limited to Bazett's corrected QT (QTcB) interval >450 milliseconds (msec) for men and >470 msec for women]
- have a history within the last 2 years or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- have a history of drug or alcohol abuse, or regularly use known drugs of abuse
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 |
|---|---|---|
| LY2584702 Reference FormulationAdministered orally | Drug | Part A: 25 mg RF, Part B: Sequence 2, Part B: Sequence 3, Part B: Sequence 4 |
| LY2584702 Test FormulationAdministered orally | Drug | Part B: Sequence 1, Part B: Sequence 2, Part B: Sequence 3, Part B: Sequence 4 |
| PlaceboAdministered orally | Drug | Part A: Placebo, Part B: Sequence 1, Part B: Sequence 2, Part B: Sequence 3, Part B: Sequence 4 |
Primary outcome
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)
Time frame: Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose]
The Cmax following a single oral dose of LY2584702 test formulation [TF (tablet)] or reference formulation [RF (capsule)] is reported.
4 secondary outcomes
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC)
Time frame: Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose]
Part B: Baseline-Adjusted Change-From-Predose in the Concentration of Lipids (Total Cholesterol)
Time frame: Part B: Baseline [Periods 1 and 4a (Day -1)], Periods 3, 4a (Day 1). Lipid concentration measurements were performed at time point 0 and 1 hour (h), 3 h, 4 h, 6 h, 10 h, and 24 h.
Part A: QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1
Time frame: Part A: Baseline [Day 1 (Predose)] and Day 1 (3 h, 4 h, 6 h, and 24 h postdose)
Part B: Average Time-Matched QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1
Time frame: Part B: Baseline [Period 1 (Day -1)] and Periods 1 to 4 (Day 1). Electrocardiograms (ECG) were performed at time point 0 and 3 h, 4 h, 6 h, and 24 h.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- 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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
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 LY2584702 Reference Formulation and LY2584702 Test Formulation in people with Healthy Participants, run by Eli Lilly and Company at 1 site in Singapore.
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 14 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 22 Jan 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 Singapore. 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?
Yes. Results are posted in the registry (first posted 22 Jan 2019). 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?
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) (time frame: Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose]). 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 22 Jan 2019.