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 range18 Years – 60 Years
SexALL
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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
✕. 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.
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
✕. 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.