MalariaPhase 1NCT04456634
Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of Ruxolitinib With Artemether-lumefantrine
A Phase 1 study testing 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux) in people with Malaria, run by Medicines for Malaria Venture at 1 site in Australia.
Trial summary
Phase 1, single -center study in 2 parts. The study designs for each part are well established for first-in-human studies and are appropriate to assess safety, tolerability and preliminary pharmacokinetics\& pharmacodynamics. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Sep 2020to 17 Nov 2020
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female (non-pregnant, non-lactating) aged 18 to 55 years inclusive.
- Contactable and available for the duration of the trial and for up to two weeks following the EOS visit.
- Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive) at Screening and Day -1. BMI is an estimate of body weight adjusted for height. It is calculated by dividing the weight in kilograms by the square of the height in metres.
- Health status
- Certified as healthy by a comprehensive clinical assessment (detailed medical history, full physical examination and special investigations).
- Vital signs measured after 5 min in the supine position:
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- Systolic blood pressure (SBP) - 90-140 mmHg,
- Diastolic blood pressure (DBP) - 40-90 mmHg,
- Heart rate (HR) 40-100 bpm.
- ECG parameters for both males and females: QT ≤ 500 msec, QTcF ≤450 msec, QTcB ≤450 msec; PR interval ≤210 msec.
- Heterosexual female participants of childbearing potential who have, or may have, male sexual partners during the course of the study should be using an insertable (implant or IUD), injectable, transdermal or combination oral contraceptive approved by the TGA combined with a barrier contraceptive from the time of informed consent until EOS. Abstinent female participants must agree to start a double method if they start a sexual relationship with a male during the trial. Female participants must not be planning in vitro fertilisation within the required contraception period.
- Women of non-childbearing potential who will not require contraception during the trial are defined as: surgically sterile (tubal ligation is not considered surgically sterile), post-menopausal (spontaneous amenorrhoea for ≥12 months, or spontaneous amenorrhoea for 6-12 months and follicle-stimulating hormone (FSH) ≥40 IU/mL; either should be together with the absence of oral contraceptive use for >12 months).
- Male participants who have, or may have female sexual partners during the course of the study must agree to use a double method of contraception including condom plus diaphragm, or condom plus stable insertable (implant or IUD), injectable, transdermal or combination oral contraceptive by the female partner, from the time of informed consent through to EOS. Abstinent male participants must agree to start a double method if they begin a sexual relationship with a female during the trial, and through to EOS. Male participants with female partners that are surgically sterile or post-menopausal, or male participants who have undergone sterilisation and have had testing to confirm the success of the sterilisation, may also be included and will not be required to use above described methods of contraception.
- Regulations
- Completion of the written informed consent process prior to undertaking any trial-related procedure.
- Must be willing and able to communicate and participate in the whole trial.
- Agree to adhere to Lifestyle Considerations (see Section 4.3.3) throughout trial duration and be willing to consume 250 mL full-fat milk with each dose of AL.
Who cannot join
- Medical history and clinical status
- Known hypersensitivity to ruxolitinib, artesunate or any of its excipients, artemether, lumefantrine or other artemisinin derivatives, proguanil/atovaquone, primaquine, or 4-aminoquinolines.
- Haematology, biochemistry or urinalysis results that are abnormal/outside of the laboratory normal reference ranges AND are either:
- Considered clinically signficant by the Principal Investigator or delegate; OR
- Considered not clinically significant by the Principal Investigator or delegate BUT ARE ALSO outside of Sponsor-approved clinically acceptable laboratory ranges in Appendix 1.
- NOTE: Participants are not excluded if abnormal/out of laboratory normal reference range results are considered not clinically significant by the Principal Investigator or delegate AND are within the ranges specified in Appendix 1.
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- Platelets < 200x109/L at Screening or prior to IMP administration is exclusionary. One re-test is permitted if original test result does not reflect the assumed medical status of the individual.
- Participation in any other investigational product trial within 5 half-lives or 12 weeks preceding IMP administration, whichever is longer, or in the exclusion period of a previous trial according to applicable regulations.
- Symptomatic postural hypotension at screening and pre-first dose of IMP on Day 1 (confirmed on two consecutive readings), irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 2-3 min when changing from supine to standing position.
- History or presence of diagnosed (by an allergist/immunologist) or treated (by a physician) food or known drug allergies, or any history of anaphylaxis or other severe allergic reactions including face, mouth, or throat swelling or any difficulty breathing. Participants with seasonal allergies/hay fever or allergy to animals or house dust mite that are untreated and asymptomatic at the time of dosing can be enrolled in the trial.
- History of convulsion (including drug or vaccine-induced episodes). A medical history of a single febrile convulsion during childhood is not an exclusion criterion.
- Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immuno-deficiencies), insulin-dependent and non-insulin-dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, porphyria, psoriasis, rheumatoid arthritis, asthma (excluding childhood asthma), epilepsy, or obsessive-compulsive disorder.
- History of malignancy of any organ system (other than localised and considered cured basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within five years of screening, regardless of whether there is no evidence of local recurrence or metastases.
- Individuals with history of schizophrenia, bipolar disorder psychoses, disorders requiring lithium, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis including generalised anxiety disorder.
- Individuals who have been hospitalised within five years prior to enrolment for either a psychiatric illness or due to danger to self or others.
- History of an episode of mild/moderate depression lasting more than 6 months that required pharmacological therapy and/or psychotherapy within the last 5 years; or any episode of major depression. The Beck Depression Inventory (BDI-II) will be used as a validated tool for the assessment of depression at screening. In addition to the conditions listed above, individuals with a score of 20 or more on the BDI-II and/or a response of 1, 2 or 3 for item 9 of this inventory (related to suicidal ideation) will not be eligible for participation. These individuals will be referred to a general practitioner or medical specialist as appropriate. Individuals with a BDI-II score of 17 to 19 may be enrolled at the discretion of an Investigator if they do not have a history of the psychiatric conditions mentioned in this criterion and their mental state is not considered to pose additional risk to the health of the individual or to the execution of the trial and interpretation of the data gathered.
- History of recurrent headache (e.g. tension-type, cluster, or migraine) with a frequency of ≥2 episodes per month on average and severe enough to require medical therapy, during the 2 years preceding screening.
- Acute illness within the 4 weeks prior to screening and prior to IMP administration.
- Significant inter-current disease of any type, in particular liver, renal, cardiac, pulmonary, neurologic, rheumatologic, or autoimmune disease by history, physical examination, and/or laboratory studies including urinalysis.
- Individual has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion (e.g. gastrectomy, cholecystectomy, diarrhoea) or known lactose/dairy intolerance.
- Participation in any research trial involving blood sampling (more than 300 mL/unit of blood) within one month prior to IMP administration, or blood donation to Australian Red Cross Blood Service (Blood Service) or other blood bank during the 8 weeks prior to IMP administration.
- Medical requirement for intravenous immunoglobulin or blood transfusions.
- History or presence of alcohol abuse (alcohol consumption more than 40 g/4 units/4 standard drinks per day), or drug habituation, or any prior intravenous usage of an illicit substance.
- Any individual who has ever smoked >1 pack of cigarettes per day for >10 years, or who currently (within 14 days prior to Screening or prior to IMP administration smokes >5 cigarettes/day.
- Female who is breastfeeding.
- Any vaccination within the last 28 days prior to screening or prior to IMP administration.
- Prior to screening or IMP administration: any systemic or inhaled corticosteroids, anti-inflammatory drugs (excluding commonly used over-the-counter anti-inflammatory drugs such as ibuprofen, acetylsalicylic acid, diclofenac), immunomodulators or anticoagulants within the past three months. Any topical, nasal or ophthalmic corticosteroids within the past 2 weeks. Any individual currently receiving or having previously received immunosuppressive therapy (including systemic steroids, adrenocorticotrophic hormone or inhaled steroids) at a dose or duration potentially associated with hypothalamic-pituitary-adrenal axis suppression within the past year.
- Use of antidepressant medication in the past 12 months prior to screening or prior to IMP administration.
- Use of any other medication except contraceptives (including herbal, vitamin supplement, OTC or prescription) within 14 days or five half-lives (whichever is longest) prior to IMP administration. Participants areCONFIDENTIAL Page 7 of 78 requested to refrain from taking non-approved concomitant medications from recruitment until the conclusion of the trial.
- Cardiac/QT risk:
- Family history of sudden death or of congenital prolongation of the QTc interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval.
- History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
- Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia, or hypomagnesaemia.
- ECG abnormalities in the standard 12-lead ECG (at screening or prior to IMP administration) which in the opinion of an Investigator is clinically relevant or will interfere with the ECG analyses.
- General conditions
- Any individual who, in the judgement of an Investigator, is likely to be non-compliant during the trial, or is unable to cooperate because of a language problem or poor mental development.
- Any individual for whom study participation would pose an additional safety risk as assessed by the Principal Investigator.
- Any individual who is an Investigator, research assistant, pharmacist, trial coordinator, or other staff thereof, directly involved in conducting the trial.
- Any individual without good peripheral venous access. Biological status
- Positive result on any of the following tests: hepatitis B surface antigen (HBs Ag), anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab).
- Recent herpes zoster infection (within the previous 6 months) as determined by clinical history.
- Positive result for M. tuberculosis infection by QuantiFERON-TB Gold assay.
- Positive urine drug test for any drug listed in Section 7.4.5. Any individual testing positive for acetaminophen (paracetamol) at screening and/or pre-dose may still be eligible for trial participation at the discretion of the Principal Investigator or delegate.
- Positive alcohol breath test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single Blind, Placebo Controlled, Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of Ruxolitinib When Co-administered With Artemether-lumefantrine in Healthy Participants
Phase 1, single -center study in 2 parts. The study designs for each part are well established for first-in-human studies and are appropriate to assess safety, tolerability and preliminary pharmacokinetics\& pharmacodynamics.
Read the detailed description
This is a randomised, single-blinded, placebo-controlled, single centre, phase 1 trial.
Eight healthy males or females, aged between 18-55 years old, who meet all of the inclusion criteria and none of the exclusion criteria, will be enrolled.
The study will be composed of 2 groups to be enrolled sequentially.
- Group 1a (sentinel group): two participants will be randomised single-blinded such that one participant will receive AL+Rux and the other participant will receive AL+placebo.
After review of the safety and tolerability data up to and including Day 8 from Group 1a by the Safety Review Committee (SRC), a decision to proceed with Group 1b will be made.
- Group 1b will be composed of 6 participants, to be randomised single-blinded such that five participants will receive AL+Rux, and one participant will receive AL+placebo.
- Conditions
- Malaria
- Being tested
- 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux), 20 mg/120 mg artemether-lumefantrine (AL) + Placebo
- Keywords
- Saftey, Tolerability
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)Drug
Also called Sentinel Group 1 a and 1 b
Rux administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total).
20 mg/120 mg artemether-lumefantrine (AL) + PlaceboOther
Also called Sentinel Group 1 a and 1 b
Placebo administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total).
| Study group | Role | What they receive |
|---|---|---|
| AL&RUX | Experimental | Oral administration of:
• 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux) Receives: Drug: 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux) |
| AL& Placebo | Placebo comparator | 20 mg/120 mg artemether-lumefantrine (AL) + Placebo Receives: Other: 20 mg/120 mg artemether-lumefantrine (AL) + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participant With Treatment-Related Adverse Events as Assessed by CTCAE V4.03, All of Observed and Self-reported AEs Affected, by Treatment Regimen.
Incidence, severity and relationship of observed and self-reported adverse events (AEs) were reported during the study up to 28 days after AL+Rux and AL+Placebo administration in all participants by treatment regimens.
Measured: up to 28 days after AL+Rux and AL+placebo administration
Number of Participants With Changes of Systolic and Diastolic Blood Pressure
Safety signals, trends or significant differences in blood pressure between treatment groups were were reported during the study up to 28 days after AL+Rux and AL+Placebo administration in all participants by treatment regimens.
Measured: up to 28 days after AL+Rux and AL+placebo administration
Number of Participants With Changes in Heart Rate
Safety signals, trends or significant differences in heart rate ( beats / min)between treatment groups were were reported during the study up to 28 days after AL+Rux and AL+Placebo administration in all participants by treatment regimens.
Measured: up to 28 days after AL+Rux and AL+placebo administration
Number of Participants With ECG Changes
Safety signals, trends or significant differences in QT, QTcB and QTcF, QRS between treatment groups were were reported during the study up to 28 days after AL+Rux and AL+Placebo administration in all participants by treatment regimens.
Measured: up to 28 days after AL+Rux and AL+placebo administration
Secondary outcomes (1)
AUECt of pSTAT3 Inhibition
Area under the effect curve (AUECt) of pSTAT3 inhibition levels
Measured: up to 28 days after AL+Rux and AL+placebo administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start10 Sep 2020
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 2 groups each to be enrolled sequentially. Group 1a will be a sentinel group of 2 participants, and Group 1b will be composed of 6 participants; to be administered either AL + Ruxolitinib or AL + placebo.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Star Research, Nucleus Network Ltd
- Responsible party
- Sponsor
- Investigators
- Paul Griffin, MD, Principal investigator, Nucleus Network Corporate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456634
- Sponsor's protocol ID
- MMV_Ruxolitinib_19_01
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2020
- Last updated
- 9 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chughlay MF, Barnes KI, El Gaaloul M, Abla N, Mohrle JJ, Griffin P, van Giersbergen P, Reuter SE, Schultz HB, Kress A, Tapley P, Webster RA, Wells T, McCarthy JS, Barber BE, Marquart L, Boyle MJ, Engwerda CR, Chalon S. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Coadministered Ruxolitinib and Artemether-Lumefantrine in Healthy Adults. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0158421. doi: 10.1128/AAC.01584-21. Epub 2021 Oct 25.
PubMed 34694880
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single Blind, Placebo Controlled, Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Activity of Ruxolitinib When Co-administered With Artemether-lumefantrine in Healthy Participants
- ClinicalTrials.gov ID
- NCT04456634
- Acronym / sponsor ID
- MMV_Ruxolitinib_19_01
- Conditions
- Malaria
- Keywords
- Saftey, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Southern Star Research, Nucleus Network Ltd
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Posted 9 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1, single -center study in 2 parts. The study designs for each part are well established for first-in-human studies and are appropriate to assess safety, tolerability and preliminary pharmacokinetics\& pharmacodynamics.
Detailed description
This is a randomised, single-blinded, placebo-controlled, single centre, phase 1 trial.
Eight healthy males or females, aged between 18-55 years old, who meet all of the inclusion criteria and none of the exclusion criteria, will be enrolled.
The study will be composed of 2 groups to be enrolled sequentially.
- Group 1a (sentinel group): two participants will be randomised single-blinded such that one participant will receive AL+Rux and the other participant will receive AL+placebo.
After review of the safety and tolerability data up to and including Day 8 from Group 1a by the Safety Review Committee (SRC), a decision to proceed with Group 1b will be made.
- Group 1b will be composed of 6 participants, to be randomised single-blinded such that five participants will receive AL+Rux, and one participant will receive AL+placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups each to be enrolled sequentially. Group 1a will be a sentinel group of 2 participants, and Group 1b will be composed of 6 participants; to be administered either AL + Ruxolitinib or AL + placebo.
| Arm | Type | Receives |
|---|---|---|
| AL&RUX | Experimental | Drug: 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)Oral administration of: • 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux) |
| AL& Placebo | Placebo comparator | Other: 20 mg/120 mg artemether-lumefantrine (AL) + Placebo20 mg/120 mg artemether-lumefantrine (AL) + Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Male or female (non-pregnant, non-lactating) aged 18 to 55 years inclusive.
- Contactable and available for the duration of the trial and for up to two weeks following the EOS visit.
- Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive) at Screening and Day -1. BMI is an estimate of body weight adjusted for height. It is calculated by dividing the weight in kilograms by the square of the height in metres.
- Health status
- Certified as healthy by a comprehensive clinical assessment (detailed medical history, full physical examination and special investigations).
Key exclusion criteria (44 listed)
- Medical history and clinical status
- Known hypersensitivity to ruxolitinib, artesunate or any of its excipients, artemether, lumefantrine or other artemisinin derivatives, proguanil/atovaquone, primaquine, or 4-aminoquinolines.
- Haematology, biochemistry or urinalysis results that are abnormal/outside of the laboratory normal reference ranges AND are either:
- NOTE: Participants are not excluded if abnormal/out of laboratory normal reference range results are considered not clinically significant by the Principal Investigator or delegate AND are within the ranges specified in Appendix 1.
- Platelets < 200x109/L at Screening or prior to IMP administration is exclusionary. One re-test is permitted if original test result does not reflect the assumed medical status of the individual.
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 |
|---|---|---|
| 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)Also: Sentinel Group 1 a and 1 bRux administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total). | Drug | AL&RUX |
| 20 mg/120 mg artemether-lumefantrine (AL) + PlaceboAlso: Sentinel Group 1 a and 1 bPlacebo administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total). | Other | AL& Placebo |
Primary outcome
Number of Participant With Treatment-Related Adverse Events as Assessed by CTCAE V4.03, All of Observed and Self-reported AEs Affected, by Treatment Regimen.
Time frame: up to 28 days after AL+Rux and AL+placebo administration
Incidence, severity and relationship of observed and self-reported adverse events (AEs) were reported during the study up to 28 days after AL+Rux and AL+Placebo administration in all participants by treatment regimens.
Number of Participants With Changes of Systolic and Diastolic Blood Pressure
Time frame: up to 28 days after AL+Rux and AL+placebo administration
Safety signals, trends or significant differences in blood pressure between treatment groups were were reported during the study up to 28 days after AL+Rux and AL+Placebo administration in all participants by treatment regimens.
Number of Participants With Changes in Heart Rate
Time frame: up to 28 days after AL+Rux and AL+placebo administration
Safety signals, trends or significant differences in heart rate ( beats / min)between treatment groups were were reported during the study up to 28 days after AL+Rux and AL+Placebo administration in all participants by treatment regimens.
Number of Participants With ECG Changes
Time frame: up to 28 days after AL+Rux and AL+placebo administration
Safety signals, trends or significant differences in QT, QTcB and QTcF, QRS between treatment groups were were reported during the study up to 28 days after AL+Rux and AL+Placebo administration in all participants by treatment regimens.
1 secondary outcome
AUECt of pSTAT3 Inhibition
Time frame: up to 28 days after AL+Rux and AL+placebo administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34694880Chughlay MF, Barnes KI, El Gaaloul M, Abla N, Mohrle JJ, Griffin P, van Giersbergen P, Reuter SE, Schultz HB, Kress A, Tapley P, Webster RA, Wells T, McCarthy JS, Barber BE, Marquart L, Boyle MJ, Engwerda CR, Chalon S. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Coadministered Ruxolitinib and Artemether-Lumefantrine in Healthy Adults. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0158421. doi: 10.1128/AAC.01584-21. Epub 2021 Oct 25.
- Individual participant dataSharing planned: No
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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.
Paul Griffin, MD principal investigator
Nucleus Network Corporate
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 20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux) in people with Malaria, run by Medicines for Malaria Venture at 1 site in Australia.
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 17 inclusion and 44 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 9 Jul 2021. 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 Australia. 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 9 Jul 2021). 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?
Number of Participant With Treatment-Related Adverse Events as Assessed by CTCAE V4.03, All of Observed and Self-reported AEs Affected, by Treatment Regimen. (time frame: up to 28 days after AL+Rux and AL+placebo administration). The study lists 4 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 NCT04456634, 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 9 Jul 2021.