MalariaPhase 1/2NCT02783833

MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects, Part B

A Phase 1/2 study testing MMV390048 40mg and MMV390048 dose to be determined mg in people with Malaria, run by Medicines for Malaria Venture at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Malaria
What is being tested?: MMV390048 40mg and MMV390048 dose to be determined mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteAustralia
Study dates: May 2016to 16 Jan 2017
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 18 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.).
Any history of malaria.
Participation in a previous malaria challenge study or Part A of the current study.
Participation in a malaria vaccine trial.
Has travelled to or lived (for more than 2 weeks) in a malaria-endemic country during the past 12 months.
Any plan to travel to a malaria-endemic country during the course of the study.
Evidence of increased cardiovascular disease risk (defined as >10%, 5 year risk for those greater than 35 years of age, as determined by the Australian Absolute Cardiovascular Disease Risk Calculator.39 Risk factors include sex, age, systolic blood pressure (mm/Hg), smoking status, total and HDL cholesterol (mmol/L), and reported diabetes status.
Frequent headaches and/or migraine, recurrent nausea, and/or vomiting (more than twice a month).
Subject unwilling to defer blood donations to the ARCBS for 6 months.
Subject who has ever received a blood transfusion.
Subject currently receiving, or having previously received, immunosuppressive therapy (including systemic steroids, adrenocorticotrophic hormone or inhaled steroids) at a dose or duration associated with hypothalamic-pituitary-adrenal axis suppression (e.g. 1 mg/kg/day of prednisone or its equivalent, or chronic use of inhaled high potency corticosteroids such as budesonide 800 μg per day or fluticasone 750 μg).
Any recent (<6 weeks) or current systemic therapy with drugs known to have potential antimalarial activity listed in Section 6.5.2.
Known allergy to one of the rescue medication proposed for the challenge study.
Subject is unwilling to abstain from consumption of quinine containing foods/beverages such as tonic water, lemon bitter, from inoculation (Day In0) to the end of the antimalarial treatment.
Subject lives alone (at any stage from Day In0 until at least the end of the antimalarial drug treatment).

Trial locations and contacts

1 site in 1 country.

Australia1 site

Q-Pharm Clinics
Herston, Queensland, 4006

Other trials in Australia

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

Read the detailed description

Pharmacodynamic profiling will also be studied to characterize the effects of MMV390048 on P. falciparum clearance kinetics in healthy subjects using the Induced Blood Stage Malaria (IBSM) challenge model to determine the minimum inhibitory concentration of MMV390048 for P. falciparum (Part B). An approximation of this concentration in healthy subjects will help to identify the optimal dose of MMV390048 for subsequent Phase 2 studies in patients. The challenge model will enable characterization of the exposure-response relationship for MMV390048 and will also provide data regarding the safety and tolerability of MMV390048 in a controlled disease-like setting.

Conditions: Malaria
Being tested: MMV390048 40mg, MMV390048 dose to be determined mg
Keywords: malaria, induced blood stage model challenge
Medical subject headings: Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MMV390048 40mgDrug
MMV390048 dose to be determined mgDrug
Cohort 2 will receive a single dose of MMV390048. Depending on the data obtained from the 40mg cohort, the dose in Cohort 2 will be determined.

Study groups in NCT02783833
Study group	Role	What they receive
MMV390048 40 mg	Experimental	MMV390048 40 mg, tablets, single dose Receives: Drug: MMV390048 40mg
MMV390048 dose to be determined mg	Experimental	MMV390048 dose to be determined mg, tablets, single dose Receives: Drug: MMV390048 dose to be determined mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect on parasites
The effect of a single oral dose of MMV390048 on P. falciparum blood stage parasites in healthy volunteers with induced blood stage malaria as observed over a period of 28 days post dosing, through:
- qPCR analysis of parasite clearance, and
- calculation of the parasite reduction ratio (PRR)
Measured: 28 days

Secondary outcomes (8)

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
observed and self reported adverse events
The incidence, severity and relationship to the investigational product of observed and self-reported adverse events during 28 days post administration of a single oral dose of MMV390048 to healthy volunteers with induced blood stage malaria.
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 201616 Jan 2017

First posted26 May 2016 (estimated)
Study startMay 2016
Primary completion16 Jan 2017
Study completion16 Jan 2017

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 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02783833
Sponsor's protocol ID: MMV_MMV390048_16_01, Part B
Status last verified: Feb 2017
First submitted: 19 May 2016
Last updated: 8 Feb 2017
Results posted: No
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, subject withdrawals, significant protocol deviations, SAEs.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2017. 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: NCT02783833
Acronym / sponsor ID: MMV_MMV390048_16_01, Part B
Conditions: Malaria
Keywords: malaria, induced blood stage model challenge
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 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 (actual)
Primary completion: 16 Jan 2017 (actual)
Study completion: 16 Jan 2017 (actual)
First posted: 26 May 2016 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MMV390048 40 mg	Experimental	Drug: MMV390048 40mgMMV390048 40 mg, tablets, single dose
MMV390048 dose to be determined mg	Experimental	Drug: MMV390048 dose to be determined mgMMV390048 dose to be determined mg, tablets, single dose

Who may qualify

Ages: 18 to 18 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 (62 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 40mg	Drug	MMV390048 40 mg
MMV390048 dose to be determined mgCohort 2 will receive a single dose of MMV390048. Depending on the data obtained from the 40mg cohort, the dose in Cohort 2 will be determined.	Drug	MMV390048 dose to be determined mg

Primary outcome

Effect on parasites
Time frame: 28 days
The effect of a single oral dose of MMV390048 on P. falciparum blood stage parasites in healthy volunteers with induced blood stage malaria as observed over a period of 28 days post dosing, through: * qPCR analysis of parasite clearance, and * calculation of the parasite reduction ratio (PRR)

8 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
observed and self reported adverse events
Time frame: 28 days

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 8 Feb 2017.
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, subject withdrawals, significant protocol deviations, SAEs.

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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 1/2 study testing MMV390048 40mg and MMV390048 dose to be determined 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 62 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 8 Feb 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on parasites (time frame: 28 days). 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 NCT02783833, 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 8 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.