Malaria drug combo under microscope: safety first
NCT ID NCT07470424
First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times
Summary
This early-stage trial will give 24 healthy adults three different malaria drugs—piperaquine, pyronaridine, and artesunate—alone and together to see how they interact. Researchers will measure drug levels in the blood and watch for side effects. The goal is to learn about safety and dosing, not to treat malaria.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- piperaquine, pyronaridine, and artesunate
- What this could lead to
- If successful, this study could help doctors understand how to combine these malaria drugs more safely and effectively.
- What could go wrong
- This is a very early, small study in 24 healthy people, not patients. It only looks at drug levels and safety, not whether the drugs cure malaria.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination. 2. Male or female non-smoker aged between 18 years to 60 years, weighting between 45 and 85 kg. 3. A female is eligible to 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 * or of childbearing potential, has a negative serum pregnancy test at screening and prior to start the study drug in each period, and agrees to abstain from sexual intercourse or use 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 4. Normal electrocardiogram (ECG) with QTc \<450 msec. 5. Willingness and ability to comply with the study protocol for the duration of the trial. 6. Participants is willing and able to give written informed consent for participation in the study Exclusion Criteria: 1. Females who are pregnant, trying to get pregnant, or are lactating. 2. The participant has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions. 3. A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening. 4. Participants with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes (heart failure, hypokalemia) or with a family history of long QT syndrome, Brugada syndrome, or sudden cardiac death. 5. Abnormal serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) \<70 mL/min as determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 6. History of alcohol or substance abuse or dependence within 6 months of the study. 7. 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 the investigator, the medication will not interfere with the study procedures or compromise participant safety; the investigator will take advice from the manufacturer representative as necessary. 8. The participant has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 times the drug half-life, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication. 9. The participant 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. 10. Participants 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. 11. Participants 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, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled. 12. 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. 13. AST or ALT \>1.5 times the upper limit of normal (ULN) 14. History of antimalarial drugs use including but not limited to mefloquine, chloroquine, primaquine, artesunate, piperaquine and pyronaridine treatment within 6 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medical Therapeutic Unit, Faculty of Tropical Medicine
Bangkok, Bangkok, 10400, Thailand
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