HealthyPhase 4NCT02324738
Pharmacokinetic and Pharmacodynamic Study of Mefloquine and Dihydroartemisinin-Piperaquine in Healthy Subjects
A Phase 4 study testing Mefloquine and Dihydroartemisinin-piperaquine, Wash-out period and Mefloquine in people with Healthy, run by University of Oxford at 1 site in Thailand.
Trial summary
This is an open-label sequential pharmacokinetic study in 16 healthy glucose-6-phosphate dehydrogenase (G6PD) normal Thai subjects at Faculty of Tropical medicine, Mahidol university. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mefloquine and Dihydroartemisinin-piperaquine, Wash-out period and Mefloquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2015to May 2015
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
- Males and Females non-smoker aged between 18 years to 60 years.
- Males and Females weight between 36-75 kilograms.
- A female is eligible to enter and participate in this study if she is:
- of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy
- or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels >40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
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- or of childbearing potential, has a negative serum pregnancy test at screening and prior to start the study drug in each period, and abstain from sexual intercourse or agrees to using effective contraceptive methods (e.g., intrauterine device, hormonal contraceptive drug, tubal ligation or female barrier method with spermicide) during the study until completion of the follow-up procedures
- A male is eligible to enter and participate in this study if he: agrees to abstain from (or use a condom during) sexual intercourse with females of childbearing potential or lactating females; or is willing to use a condom/spermicide, during the study until completion of the follow-up procedures.
- Provide a signed and dated written informed consent prior to study participation.
- Normal electrocardiogram (ECG) with QTc <450 msec.
- Willingness and ability to comply with the study protocol for the duration of the trial.
Who cannot join
- Females who are pregnant, trying to get pregnant, or are lactating.
- The subject has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
- A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de points (heart failure, hypokalemia) or with a family history of sudden cardiac death.
- A creatinine clearance <70 mL/min as determined by Cockcroft-Gault equation:
- Creatinine clearance (CLcr (mL/min)) = (140 - age) Wt / (72 Scr) (multiply answer by 0.85 for females) Where age is in years, weight (wt) is in kg, and serum creatinine (Scr) is in units of mg/dL [Cockcroft, 1976].
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- History of alcohol or substance abuse or dependence within 6 months of the study.
- Use of prescription or non-prescription drugs except paracetamol at doses of up to 2 grams/day, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise subject safety; the investigator will take advice from the manufacturer representative as necessary.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-life, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.
- The subject is unwilling to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample during each regimen.
- Subjects who have donated blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period. Note: This does not include plasma donation.
- Subjects who have a history of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the trial. In addition, if heparin is used during pharmacokinetic sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- Lack of suitability for participation in this study, including but not limited to, unstable medical conditions, systemic disease manifested by tendency to granulocytopenia e.g. rheumatoid arthritis and lupus erythematosus that in the opinion of the investigator would compromise their participation in the trial.
- Aspartate transaminase (AST) or Alanine transaminase (ALT) >1.5 upper limit of normal (ULN)
- Subjects with history of renal disease, hepatic disease, and/or cholecystectomy
- History of antimalarial drugs use including but not limited to mefloquine, chloroquine, primaquine, artesunate, piperaquine and pyronaridine treatment within 3 months.
- Subject who received quinacrine in last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Study to Evaluate Potential Pharmacokinetic and Pharmacodynamic Interactions of Orally Administered Mefloquine and Dihydroartemisinin-Piperaquine in Healthy Adult Subjects
This is an open-label sequential pharmacokinetic study in 16 healthy glucose-6-phosphate dehydrogenase (G6PD) normal Thai subjects at Faculty of Tropical medicine, Mahidol university.
The 16 subjects have already participated in a healthy volunteer studies in the past either i) Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered primaquine and dihydroartemisinin-piperaquine (DHA-PQP) in Healthy Adult Subjects or ii) Comparison of the electrocardiographic effects in relation to Pharmacokinetic profile of chloroquine and piperaquine in healthy Thai subjects
Every subject was administered a single dose of three tablets of DHA-PQP from previous studies. To avoid unnecessary exposure of DHA-PQP again, we propose to include the results of DHA-PQP arm from these previous studies and ask the healthy subjects to participate this study for receiving only single dose of three tablet of DHA-PQP (40mg/320mg) and two tablet of Mefloquine (250mg) on first admission and single dose of two tablet of Mefloquine on second admission.
Read the detailed description
Artemisinin resistance poses the greatest threat to current global initiatives to control and eliminate malaria. The World Health Organisation recommends the use of the artemisinin combination therapy (one partner drug combine with artemisinin as the back bone) (ACTs) instead of the single drug. The reduction in artemisinin sensitivity has left partner drugs within ACTs exposed too much larger number of parasites and unsurprisingly cure rates with ACTs have begun to fall substantially.
Recently, the Mahidol Oxford Tropical Medicine Research Unit (MORU) has applied for and received funding for an extension of the TRAC project. The proposed extension project, named TRACII, will further map artemisinin and partner drug resistance in the South-East Asian region. Also, TRACII aims to investigate the safety, pharmacokinetic characteristics and efficacy of a novel combination of an artemisinin-derivative and two long acting partner drugs, piperaquine and mefloquine.
It is necessary that the potential drug-drug interactions of mefloquine and dihydroartemisinin-piperaquine (DHA-PQP) are characterized. Piperaquine and Mefloquine are both metabolized by Cytochrome P450 3A4 (abbreviated CYP3A4) enzyme which potentially results in clinically significant drug-drug interactions that can cause unanticipated adverse reactions or therapeutic failures because of the suboptimal drug exposures to the parasite.
The study will evaluate the pharmacokinetic interaction and safety profile focusing on the cardiogenic effect (QTc prolongation) of this triple combinations of DHA-PQP and mefloquine. Piperaquine and Mefloquine are both metabolized by Cytochrome P450 3A4 enzyme which potentially results in clinically significant drug-drug interactions.
These safety and pharmacokinetic data will be translated to support the intervention in the Tracking Resistance to Artemisinin Collaboration II (TRACII) project.
This is an open-label sequential pharmacokinetic study in 16 healthy G6PD normal Thai subjects. The 16 subjects have participated in a healthy volunteer studies in the past either i) Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered primaquine and dihydroartemisinin-piperaquine in Healthy Adult Subjects or ii) Comparison of the electrocardiographic effects in relation to Pharmacokinetic profile of chloroquine and piperaquine in healthy Thai subjects in which they were administered a single dose of three tablets of DHA-PQP. To avoid unnecessary exposure of other healthy subjects to this study, we propose to include the result of these previous studies and ask the healthy subjects to participate from regimen 1 and onward.
Subjects will be admitted in the inpatient ward to receive 2 drug regimens: regimen 1 (Mefloquine with DHA-PQP) and regimen 2 (Mefloquine). Every subject will have 1 screening and 2 admissions in the hospital
- Conditions
- Healthy
- Being tested
- Mefloquine and Dihydroartemisinin-piperaquine, Wash-out period, Mefloquine
- Keywords
- Mefloquine/Dihydroartemisinin-piperaquine, drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mefloquine and Dihydroartemisinin-piperaquineDrug
2 tablets of mefloquine and 3 tablets of dihydroartemisinin-piperaquine single dose
Wash-out periodOther
MefloquineDrug
2 tablets of Mefloquine single dose
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Experimental | All subjects will receive Mefloquine and Dihydroartemisinin-piperaquine, wash out then will receive Mefloquine Receives: Drug: Mefloquine and Dihydroartemisinin-piperaquine; Other: Wash-out period; Drug: Mefloquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability parameters (including adverse events, clinical laboratory, and vital signs assessments)
Safety and tolerability parameters, including adverse events, clinical laboratory, and vital signs assessments, in particular QTc prolongation for DHA-PQP in combination with mefloquine.
Measured: approximately 4 months
Area under the curve and maximum concentration
Area under the concentration-time curve [AUC 0-∞ and AUC 0-last] and maximal concentration (Cmax) for mefloquine and metabolites when given alone and together with DHA-PQP.
Measured: approximately 36 days
Area under the curve and maximum concentration
Area under the concentration-time curve [AUC0-∞ and AUC0-last] and maximal concentration (Cmax) for piperaquine and dihydroartemisinin when given alone as DHA-PQP and together with mefloquine.
Measured: approximately 36 days
Secondary outcomes (2)
Pharmacokinetic parameters ((i.e. elimination clearance (CL/F), terminal elimination half-life (t1/2) and apparent volume of distribution (Vd)
Estimate pharmacokinetic parameters (i.e. elimination clearance (CL/F), terminal elimination half-life (t1/2) and apparent volume of distribution (Vd) for mefloquine, dihydroartemisinin and piperaquine when given alone and in combination.
Measured: approximately 36 days
Genetic abnormality
In case of any abnormal metabolisms in individuals, related genetic tests may be performed to determine if there is any genetic abnormality. Such data may be useful in predicting those who may not obtain the full therapeutic or prophylactic benefit of study drugs.
Measured: approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 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 HealthyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324738
- Sponsor's protocol ID
- TMEC 14-069
- Status last verified
- Nov 2015
- First submitted
- 15 Dec 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hanboonkunupakarn B, van der Pluijm RW, Hoglund R, Pukrittayakamee S, Winterberg M, Mukaka M, Waithira N, Chotivanich K, Singhasivanon P, White NJ, Dondorp AM, Tarning J, Jittamala P. Sequential Open-Label Study of the Safety, Tolerability, and Pharmacokinetic Interactions between Dihydroartemisinin-Piperaquine and Mefloquine in Healthy Thai Adults. Antimicrob Agents Chemother. 2019 Jul 25;63(8):e00060-19. doi: 10.1128/AAC.00060-19. Print 2019 Aug.
PubMed 31182525
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study to Evaluate Potential Pharmacokinetic and Pharmacodynamic Interactions of Orally Administered Mefloquine and Dihydroartemisinin-Piperaquine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02324738
- Acronym / sponsor ID
- TMEC 14-069
- Conditions
- Healthy
- Keywords
- Mefloquine/Dihydroartemisinin-piperaquine, drug interaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 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.
This is an open-label sequential pharmacokinetic study in 16 healthy glucose-6-phosphate dehydrogenase (G6PD) normal Thai subjects at Faculty of Tropical medicine, Mahidol university.
The 16 subjects have already participated in a healthy volunteer studies in the past either i) Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered primaquine and dihydroartemisinin-piperaquine (DHA-PQP) in Healthy Adult Subjects or ii) Comparison of the electrocardiographic effects in relation to Pharmacokinetic profile of chloroquine and piperaquine in healthy Thai subjects
Every subject was administered a single dose of three tablets of DHA-PQP from previous studies. To avoid unnecessary exposure of DHA-PQP again, we propose to include the results of DHA-PQP arm from these previous studies and ask the healthy subjects to participate this study for receiving only single dose of three tablet of DHA-PQP (40mg/320mg) and two tablet of Mefloquine (250mg) on first admission and single dose of two tablet of Mefloquine on second admission.
Detailed description
Artemisinin resistance poses the greatest threat to current global initiatives to control and eliminate malaria. The World Health Organisation recommends the use of the artemisinin combination therapy (one partner drug combine with artemisinin as the back bone) (ACTs) instead of the single drug. The reduction in artemisinin sensitivity has left partner drugs within ACTs exposed too much larger number of parasites and unsurprisingly cure rates with ACTs have begun to fall substantially.
Recently, the Mahidol Oxford Tropical Medicine Research Unit (MORU) has applied for and received funding for an extension of the TRAC project. The proposed extension project, named TRACII, will further map artemisinin and partner drug resistance in the South-East Asian region. Also, TRACII aims to investigate the safety, pharmacokinetic characteristics and efficacy of a novel combination of an artemisinin-derivative and two long acting partner drugs, piperaquine and mefloquine.
It is necessary that the potential drug-drug interactions of mefloquine and dihydroartemisinin-piperaquine (DHA-PQP) are characterized. Piperaquine and Mefloquine are both metabolized by Cytochrome P450 3A4 (abbreviated CYP3A4) enzyme which potentially results in clinically significant drug-drug interactions that can cause unanticipated adverse reactions or therapeutic failures because of the suboptimal drug exposures to the parasite.
The study will evaluate the pharmacokinetic interaction and safety profile focusing on the cardiogenic effect (QTc prolongation) of this triple combinations of DHA-PQP and mefloquine. Piperaquine and Mefloquine are both metabolized by Cytochrome P450 3A4 enzyme which potentially results in clinically significant drug-drug interactions.
These safety and pharmacokinetic data will be translated to support the intervention in the Tracking Resistance to Artemisinin Collaboration II (TRACII) project.
This is an open-label sequential pharmacokinetic study in 16 healthy G6PD normal Thai subjects. The 16 subjects have participated in a healthy volunteer studies in the past either i) Open-Label Study to Evaluate Potential Pharmacokinetic Interaction of Orally Administered primaquine and dihydroartemisinin-piperaquine in Healthy Adult Subjects or ii) Comparison of the electrocardiographic effects in relation to Pharmacokinetic profile of chloroquine and piperaquine in healthy Thai subjects in which they were administered a single dose of three tablets of DHA-PQP. To avoid unnecessary exposure of other healthy subjects to this study, we propose to include the result of these previous studies and ask the healthy subjects to participate from regimen 1 and onward.
Subjects will be admitted in the inpatient ward to receive 2 drug regimens: regimen 1 (Mefloquine with DHA-PQP) and regimen 2 (Mefloquine). Every subject will have 1 screening and 2 admissions in the hospital
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | Experimental | Drug: Mefloquine and Dihydroartemisinin-piperaquine, Other: Wash-out period, Drug: MefloquineAll subjects will receive Mefloquine and Dihydroartemisinin-piperaquine, wash out then will receive Mefloquine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
- Males and Females non-smoker aged between 18 years to 60 years.
- Males and Females weight between 36-75 kilograms.
- A female is eligible to enter and participate in this study if she is:
- A male is eligible to enter and participate in this study if he: agrees to abstain from (or use a condom during) sexual intercourse with females of childbearing potential or lactating females; or is willing to use a condom/spermicide, during the study until completion of the follow-up procedures.
Key exclusion criteria (17 listed)
- Females who are pregnant, trying to get pregnant, or are lactating.
- The subject has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
- A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de points (heart failure, hypokalemia) or with a family history of sudden cardiac death.
- A creatinine clearance <70 mL/min as determined by Cockcroft-Gault equation:
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 |
|---|---|---|
| Mefloquine and Dihydroartemisinin-piperaquine2 tablets of mefloquine and 3 tablets of dihydroartemisinin-piperaquine single dose | Drug | Healthy Volunteer |
| Wash-out period | Other | Healthy Volunteer |
| Mefloquine2 tablets of Mefloquine single dose | Drug | Healthy Volunteer |
Primary outcome
Safety and tolerability parameters (including adverse events, clinical laboratory, and vital signs assessments)
Time frame: approximately 4 months
Safety and tolerability parameters, including adverse events, clinical laboratory, and vital signs assessments, in particular QTc prolongation for DHA-PQP in combination with mefloquine.
Area under the curve and maximum concentration
Time frame: approximately 36 days
Area under the concentration-time curve [AUC 0-∞ and AUC 0-last] and maximal concentration (Cmax) for mefloquine and metabolites when given alone and together with DHA-PQP.
Area under the curve and maximum concentration
Time frame: approximately 36 days
Area under the concentration-time curve [AUC0-∞ and AUC0-last] and maximal concentration (Cmax) for piperaquine and dihydroartemisinin when given alone as DHA-PQP and together with mefloquine.
2 secondary outcomes
Pharmacokinetic parameters ((i.e. elimination clearance (CL/F), terminal elimination half-life (t1/2) and apparent volume of distribution (Vd)
Time frame: approximately 36 days
Genetic abnormality
Time frame: approximately 4 months
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 3 Nov 2015.
- Derived from this study: PubMed 31182525Hanboonkunupakarn B, van der Pluijm RW, Hoglund R, Pukrittayakamee S, Winterberg M, Mukaka M, Waithira N, Chotivanich K, Singhasivanon P, White NJ, Dondorp AM, Tarning J, Jittamala P. Sequential Open-Label Study of the Safety, Tolerability, and Pharmacokinetic Interactions between Dihydroartemisinin-Piperaquine and Mefloquine in Healthy Thai Adults. Antimicrob Agents Chemother. 2019 Jul 25;63(8):e00060-19. doi: 10.1128/AAC.00060-19. Print 2019 Aug.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mefloquine and Dihydroartemisinin-piperaquine, Wash-out period and Mefloquine in people with Healthy, run by University of Oxford at 1 site in Thailand.
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 17 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 3 Nov 2015. 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 Thailand. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Safety and tolerability parameters (including adverse events, clinical laboratory, and vital signs assessments) (time frame: approximately 4 months). The study lists 3 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 NCT02324738, 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 3 Nov 2015.