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.
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.
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
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.
Crossover
Piperaquine
DrugPiperaquine is an antimalarial medicine normally combined with an artemisinin derivative in the combination therapy dihydroartemisinin-piperaquine.
Artesunate-pyronaridine (Pyramax)
DrugArtesunate-pyronaridine is a medicine that contains the active substances pyronaridine tetraphosphate and artesunate.
Piperaquine and artesunate-pyronaridine (Pyramax)
DrugPiperaquine is an antimalarial medicine. Artesunate-pyronaridine is a medicine that contains the active substances pyronaridine tetraphosphate and artesunate.
6
Treatment groupsSee each treatment group below.
Number of adverse events
Adverse events will be assessed as one of safety and tolerability parameters.
Number of events concerning of abnormal electrocardiographic
Electrocardiographic changes especially QTc interval prolongation will be assessed as one of safety and tolerability parameters.
Number of events concerning of abnormal vital signs
Abnormal vital signs will be assessed as one of safety and tolerability parameters.
Number of events concerning of abnormal laboratory values
Abnormal laboratory values will be assessed as one of safety and tolerability parameters.
Area under the concentration-time curve (AUC∞)
Area under the concentration-time curve (AUC∞) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Area under the concentration-time curve (AUClast)
Area under the concentration-time curve (AUClast) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Maximum concentration (Cmax)
Maximum concentration (Cmax) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Elimination clearance (CL/F)
Elimination clearance (CL/F) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
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