A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Heal… (NCT07470424) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults
Thailand24 participantsStarted 2026-06-01
Plain-language summary
This is an open-label pharmacokinetic study in 24 healthy Thai participants. Participants will be admitted in the inpatient ward and each participant will attend a total of 4 visits, including one screening visit and three hospital admissions. Participants will be randomized into one of six groups.
Each group will receive 3 drug regimens consisting of (1) piperaquine, (2) pyronaridine plus artesunate, or (3) piperaquine, pyronaridine, and artesunate, administered once per day for three consecutive days in different sequential orders.
After each regimen, participants will be followed up for six weeks for clinical assessments and laboratory evaluations to study the pharmacokinetics. A washout period of at least eight weeks will be implemented between each regimen.
This study is funded by the Global Health Innovative Technology Fund (GHIT Fund), Tokyo, Japan, under grant number G2025-117.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
. Male or female non-smoker aged between 18 years to 60 years, weighting between 45 and 85 kg.
. A female is eligible to participate in this study if she is:
. Normal electrocardiogram (ECG) with QTc \<450 msec.
. Willingness and ability to comply with the study protocol for the duration of the trial.
. Participants is willing and able to give written informed consent for participation in the study
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of adverse events
Timeframe: Approximately 6 months
2
Number of events concerning of abnormal electrocardiographic
Timeframe: Approximately 6 months
3
Number of events concerning of abnormal vital signs
Timeframe: Approximately 6 months
4
Number of events concerning of abnormal laboratory values
. Females who are pregnant, trying to get pregnant, or are lactating.
. The participant has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions.
. A positive pre-study hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
. 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.
. Abnormal serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) \<70 mL/min as determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
. History of alcohol or substance abuse or dependence within 6 months of the study.
. Use of prescription or non-prescription drugs except paracetamol at doses of up to 2 grams/day, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of 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.
. 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.