MalariaPhase 1NCT02783820
Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A
A Phase 1 study testing MMV390048 40 mg, MMV390048 80 mg and MMV390048 120 mg in people with Malaria, run by Medicines for Malaria Venture at 1 site in Australia.
Trial summary
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A). 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?
- MMV390048 40 mg, MMV390048 80 mg and MMV390048 120 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- May 2016to Dec 2016
- 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
- Completion of the written informed consent process.
- Men or WNCBP age 18 to 55 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Male subjects agree to use acceptable methods of contraception if the male subject's partner could become pregnant from the time of the first administration of study medication until 130 (90+40) days following administration of the investigational medicinal product. One of the following acceptable methods of contraception must be utilized:
- Condom and occlusive cap (diaphragm or cervical/vault caps)
- Surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
- The subject's female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
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- The subject's female partner uses medically prescribed topically-applied transdermal contraceptive patch and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
- The subject's female partner has undergone documented tubal ligation (female sterilization). In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
- The subject's female partner has undergone documented placement of an intrauterine device or intrauterine system. In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps].
- True abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Abstinent subjects have to agree to use 1 of the above-mentioned contraceptive methods, if they start sexual relationships during the study and for up to 100 days after the last dose of study drug.
- Women subjects must be of non-childbearing potential (WNCBP) as per one of the following definitions:
- Natural (spontaneous) post-menopausal defined as being amenorrhoeic for at least 12 months without an alternative medical cause with a screening follicle stimulating hormone level consistent with local laboratory levels for post-menopause.
- Premenopausal with irreversible surgical sterilization by hysterectomy and/or bilateral oophorectomy or salpingectomy at least 6 months before screening (as determined by subject medical history).
- Haematology, clinical chemistry and urinalysis results at screening that are within the local laboratory reference range or, if outside the range, not clinically significant as judged by the Investigator. More specifically, serum creatinine, hepatic transaminase enzymes (AST ALT), and total bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper laboratory norm and haemoglobin must be equal to or higher than the lower limit of the normal range.
- Total body weight greater than 50 kg and a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive).
- Non-smoker or ex-smoker for more than 90 days prior to screening, or smoke no more than 5 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Agree to stay in contact with the study site for the duration of the study and up to 2 weeks following the end of study visit, provide updated contact information as necessary, and have no current plans to move away from the study area for the duration of the study.
Who cannot join
- Male subjects with a female partner(s) who is (are) pregnant or lactating from the time of the administration of study medication.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means.
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal (including gallbladder), cardiovascular (including a family history of long QT syndrome or sudden death), hepatic, psychiatric, neurologic, or allergic disease (including drug or food allergies, anaphylaxis or other severe allergic reactions but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of malignancy of any organ system (other than localised basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- Any surgical or medical condition possibly affecting drug absorption (e.g. cholecystectomy, gastrectomy, bowel disease, etc.), distribution, metabolism or excretion.
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- Previous splenectomy.
- A history of photosensitivity.
- Subject positive for any of the following
- Anti-human immunodeficiency virus 1 or 2 antibodies (anti-HIV1 or anti-HIV2 Ab) (ELISA)
- Hepatitis B surface antigen (HBsAg)
- Anti-hepatitis B core antibodies (anti-HBcAb)
- Anti-hepatitis C antibodies (anti-HCV)
- Resting vital signs (measured after 5 minutes in the supine position) at screening, pre-dose (Part A) or pre-inoculation (Part B) outside of the following study-specific normal ranges:
- tympanic body temperature < 38.0 °C
- 90 < SBP < 140 mmHg
- 50 < DBP < 90 mmHg
- 40 < pulse rate < 100 bpm
- Symptomatic postural hypotension at screening, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg 2 minutes after changing from a supine to standing position.
- A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening, pre-dose (Part A and B) or pre-inoculation (Part B):
- PR >210 ms
- QRS complex >120 ms
- QTcF >450 ms
- Second or third degree atrioventricular block
- Incomplete, complete or intermittent bundle branch block
- Abnormal T wave morphology
- Left ventricular hypertrophy with repolarisation abnormalities
- Right ventricular hypertrophy.
- Presence of acute infectious disease or fever (i.e. tympanic body temperature ≥38.5 ºC) within five days prior to the first dose of study medication (Part A) or the inoculation administration (Part B).
- Use of prescription or non-prescription drugs, herbal and dietary supplements within 14 days or 5 half-lives (whichever is the longer) prior to the first dose of study medication (Part A) or the inoculation administration (Part B). [As an exception, paracetamol may be used at doses of up to 1 g/day (Part A) or 2 g/day (Part B), or ibuprofen up to 1.2 g/day (Part B). Limited use of other non-prescription medications not believed to affect subject safety or the overall results of the study, may be permitted on a case-by-case basis following approval by the sponsor.]
- Recipient of any vaccination within 28 days prior to the first dose of study medication (Part A) or the inoculation administration (Part B).
- Urine drug screen at screening, pre-dose (Part A) or pre-inoculation (Part B) positive for any drug as listed in Section 9.2.4 unless there is an explanation acceptable to the medical Investigator (e.g. the subject has stated in advance that they consumed a prescription or over the counter product which contained the detected drug) and/or the subject has a negative urine drug screen on retest by the pathology laboratory.
- Ingestion of any poppy seeds within the 24 hours prior to the screening blood test.
- A positive alcohol breath test at screening, pre-dose (Part A) or pre-inoculation (Part B).
- History of regular alcohol consumption exceeding a weekly intake of more than 21 units for males and more than 14 units for females (one unit is equivalent to 8-10 g of ethanol, 285 ml of beer or lager, one glass [125 ml] of wine, or 25 ml of spirits) within 6 months of screening.
- History of drug habituation, or any prior intravenous usage of an illicit substance.
- Participation in any investigational product study within 12 weeks or five half-lives (whichever is longer) prior to the first dose of the study medication.
- Intake of grapefruit, grapefruit juice or grapefruit-related citrus fruits (e.g. Seville oranges, pomelos) within 28 days prior to the first dose of the study medication.
- Excessive consumption of beverages containing xanthine bases (e.g. more than 400 mg of caffeine per day, equivalent to approximately 4 cups of coffee).
- Pregnant or nursing (lactating) women.
- Participation in any research study involving blood sampling (more than 450 ml/ unit of blood), or blood donation to the Australian Red Cross Blood Service (ARCBS) or other blood bank during the 8 weeks prior to IMP administration (Part A) or inoculation (Part B).
- Blood donation (excluding plasma donation) of any volume, within 1 month prior to screening.
- Medical requirement for intravenous immunoglobulin or blood transfusions.
- Subject with poor peripheral venous access.
- Subject unwilling or unable to comply with the restrictions described in this protocol.
- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- Any subject who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
- Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Two-part, Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).
Read the detailed description
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).
Primary objectives:
- To evaluate the safety and tolerability of single ascending doses of MMV390048 administered orally to healthy subjects (men and WNCBP) under fasted conditions
Secondary objectives:
- To describe the pharmacokinetics of MMV390048 in healthy subjects (men and WNCBP) after single oral dose administration
- Conditions
- Malaria
- Being tested
- MMV390048 40 mg, Placebo to match MMV390048 40 mg, MMV390048 80 mg, Placebo to match MMV390048 80 mg, MMV390048 120 mg
- Keywords
- malaria, single ascending dose,
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMV390048 40 mgDrug
Placebo to match MMV390048 40 mgDrug
MMV390048 80 mgDrug
Placebo to match MMV390048 80 mgDrug
MMV390048 120 mgDrug
Placebo to match MMV390048 120 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| MMV390048 40 mg | Experimental | MMV390048 40 mg, tablets, single dose Receives: Drug: MMV390048 40 mg |
| Placebo to match MMV390048 40 mg | Placebo comparator | Placebo to match MMV390048 40 mg, tablets, single dose Receives: Drug: Placebo to match MMV390048 40 mg |
| MMV390048 80 mg | Experimental | MMV390048 80 mg, tablets, single dose Receives: Drug: MMV390048 80 mg |
| Placebo to match MMV390048 80 mg | Placebo comparator | Placebo to match MMV390048 80 mg, tablets, single dose Receives: Drug: Placebo to match MMV390048 80 mg |
| MMV390048 120 mg | Experimental | MMV390048 120 mg, tablets, single dose Receives: Drug: MMV390048 120 mg |
| Placebo to match MMV390048 120 mg | Placebo comparator | Placebo to match MMV390048 120 mg, tablets, single dose Receives: Drug: Placebo to match MMV390048 120 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of MMV390048 - Number of Adverse Events
Number of observed and self-reported Adverse Events (AE) (unexpected toxicities, adverse events encountered during or after investigational drug administration)
Measured: 28 days post administration of a single oral dose of MMV390048 to healthy volunteers
Secondary outcomes (7)
PK Cmax
Estimation of the maximum plasma concentration over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Measured: 28 days
PK Tmax
Estimation of the time to maximum plasma concentration over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Measured: 28 days
PK Total Exposure AUClast
Estimation of the last quantifiable concentration over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Measured: 28 days
PK Total Exposure AUCinf
Estimation of the area under the plasma concentration time curve over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Measured: 28 days
PK Distribution and Clearance (CL/F)
Apparent oral clearance (CL/F) over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Measured: 28 days
PK Distribution and Clearance (Vz/F)
Apparent volume of distribution (Vz/F) over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Measured: 28 days
PK Distribution and Clearance (t½)
Terminal half-life (t½) over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016
- Study completionDec 2016
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Network Services (CNS) Pty Ltd, Q-Pharm Pty Limited, QIMR Berghofer Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- James McCarthy, Prof, Principal investigator, Q-Pharm Pty Ltd and QIMR Berghofer Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783820
- Sponsor's protocol ID
- MMV_MMV390048_16_01
- Status last verified
- May 2020
- First submitted
- 19 May 2016
- Last updated
- 11 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Clinical safety data (physical exam, ECG, vital signs, clinical score, AEs) lab safety data PK data PCR data Dosing completed, subject withdrawals,significant protocol deviations. Serious Adverse Event Reports
Publications
McCarthy JS, Donini C, Chalon S, Woodford J, Marquart L, Collins KA, Rozenberg FD, Fidock DA, Cherkaoui-Rbati MH, Gobeau N, Mohrle JJ. A Phase 1, Placebo-controlled, Randomized, Single Ascending Dose Study and a Volunteer Infection Study to Characterize the Safety, Pharmacokinetics, and Antimalarial Activity of the Plasmodium Phosphatidylinositol 4-Kinase Inhibitor MMV390048. Clin Infect Dis. 2020 Dec 17;71(10):e657-e664. doi: 10.1093/cid/ciaa368.
PubMed 32239164
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Two-part, Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02783820
- Acronym / sponsor ID
- MMV_MMV390048_16_01
- Conditions
- Malaria
- Keywords
- malaria, single ascending dose,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Clinical Network Services (CNS) Pty Ltd, Q-Pharm Pty Limited, QIMR Berghofer Medical Research Institute
- Study start
- May 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).
Detailed description
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).
Primary objectives:
- To evaluate the safety and tolerability of single ascending doses of MMV390048 administered orally to healthy subjects (men and WNCBP) under fasted conditions
Secondary objectives:
- To describe the pharmacokinetics of MMV390048 in healthy subjects (men and WNCBP) after single oral dose administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MMV390048 40 mg | Experimental | Drug: MMV390048 40 mgMMV390048 40 mg, tablets, single dose |
| Placebo to match MMV390048 40 mg | Placebo comparator | Drug: Placebo to match MMV390048 40 mgPlacebo to match MMV390048 40 mg, tablets, single dose |
| MMV390048 80 mg | Experimental | Drug: MMV390048 80 mgMMV390048 80 mg, tablets, single dose |
| Placebo to match MMV390048 80 mg | Placebo comparator | Drug: Placebo to match MMV390048 80 mgPlacebo to match MMV390048 80 mg, tablets, single dose |
| MMV390048 120 mg | Experimental | Drug: MMV390048 120 mgMMV390048 120 mg, tablets, single dose |
| Placebo to match MMV390048 120 mg | Placebo comparator | Drug: Placebo to match MMV390048 120 mgPlacebo to match MMV390048 120 mg, tablets, single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Completion of the written informed consent process.
- Men or WNCBP age 18 to 55 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Male subjects agree to use acceptable methods of contraception if the male subject's partner could become pregnant from the time of the first administration of study medication until 130 (90+40) days following administration of the investigational medicinal product. One of the following acceptable methods of contraception must be utilized:
- Women subjects must be of non-childbearing potential (WNCBP) as per one of the following definitions:
- Haematology, clinical chemistry and urinalysis results at screening that are within the local laboratory reference range or, if outside the range, not clinically significant as judged by the Investigator. More specifically, serum creatinine, hepatic transaminase enzymes (AST ALT), and total bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper laboratory norm and haemoglobin must be equal to or higher than the lower limit of the normal range.
Key exclusion criteria (48 listed)
- Male subjects with a female partner(s) who is (are) pregnant or lactating from the time of the administration of study medication.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means.
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal (including gallbladder), cardiovascular (including a family history of long QT syndrome or sudden death), hepatic, psychiatric, neurologic, or allergic disease (including drug or food allergies, anaphylaxis or other severe allergic reactions but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- History of malignancy of any organ system (other than localised basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
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 |
|---|---|---|
| MMV390048 40 mg | Drug | MMV390048 40 mg |
| Placebo to match MMV390048 40 mg | Drug | Placebo to match MMV390048 40 mg |
| MMV390048 80 mg | Drug | MMV390048 80 mg |
| Placebo to match MMV390048 80 mg | Drug | Placebo to match MMV390048 80 mg |
| MMV390048 120 mg | Drug | MMV390048 120 mg |
| Placebo to match MMV390048 120 mg | Drug | Placebo to match MMV390048 120 mg |
Primary outcome
Safety of MMV390048 - Number of Adverse Events
Time frame: 28 days post administration of a single oral dose of MMV390048 to healthy volunteers
Number of observed and self-reported Adverse Events (AE) (unexpected toxicities, adverse events encountered during or after investigational drug administration)
7 secondary outcomes
PK Cmax
Time frame: 28 days
PK Tmax
Time frame: 28 days
PK Total Exposure AUClast
Time frame: 28 days
PK Total Exposure AUCinf
Time frame: 28 days
PK Distribution and Clearance (CL/F)
Time frame: 28 days
PK Distribution and Clearance (Vz/F)
Time frame: 28 days
PK Distribution and Clearance (t½)
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32239164McCarthy JS, Donini C, Chalon S, Woodford J, Marquart L, Collins KA, Rozenberg FD, Fidock DA, Cherkaoui-Rbati MH, Gobeau N, Mohrle JJ. A Phase 1, Placebo-controlled, Randomized, Single Ascending Dose Study and a Volunteer Infection Study to Characterize the Safety, Pharmacokinetics, and Antimalarial Activity of the Plasmodium Phosphatidylinositol 4-Kinase Inhibitor MMV390048. Clin Infect Dis. 2020 Dec 17;71(10):e657-e664. doi: 10.1093/cid/ciaa368.
- Individual participant dataSharing planned: Yes. Clinical safety data (physical exam, ECG, vital signs, clinical score, AEs) lab safety data PK data PCR data Dosing completed, subject withdrawals,significant protocol deviations. Serious Adverse Event Reports
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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.
James McCarthy, Prof principal investigator
Q-Pharm Pty Ltd and QIMR Berghofer Medical Research Institute
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 MMV390048 40 mg, MMV390048 80 mg and MMV390048 120 mg 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 18 inclusion and 48 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 11 Jun 2020. 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 11 Jun 2020). 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?
Safety of MMV390048 - Number of Adverse Events (time frame: 28 days post administration of a single oral dose of MMV390048 to healthy volunteers). 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 NCT02783820, 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 11 Jun 2020.