A Phase 1 interventional study of Piperaquine and Artesunate-pyronaridine (Pyramax) in Malaria, sponsored by University of Oxford. Not yet recruiting at 1 site in Thailand. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University of Oxford · Phase 1, Interventional, and Health services research
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.
This study will enroll 24 healthy Thai participants. Participants will complete one screening visit and three inpatient study periods.
Participants will be randomly assigned to one of six study groups and will receive three different study drugs in a crossover design, as described below:
Each treatment study drug will be administered for three consecutive days. The order of administration will differ by study group as follows:
Group 1 (n = 4): Study drug 1 → Study drug 2 → Study drug 3
Group 2 (n = 4): Study drug 1 → Study drug 3 → Study drug 2
Group 3 (n = 4): Study drug 2 → Study drug 1 → Study drug 3
Group 4 (n = 4): Study drug 2 → Study drug 3 → Study drug 1
Group 5 (n = 4): Study drug 3 → Study drug 1 → Study drug 2
Group 6 (n = 4): Study drug 3 → Study drug 2 → Study drug 1
After each treatment period, participants will be followed for six weeks, during which seven follow-up visits will be conducted for clinical assessments and blood sampling. A washout period of at least eight weeks will be observed between treatment periods to allow for complete elimination of the study drugs from the body.
Each participant will take part in the study for about 6 months. The entire study is expected to last about 12 months.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's planned enrollment of 24 is below the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A female is eligible to participate in this study if she is:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Piperaquine · Drug: Artesunate-pyronaridine (Pyramax) · Drug: Piperaquine and artesunate-pyronaridine (Pyramax)
Drug: Piperaquine · Drug: Artesunate-pyronaridine (Pyramax) · Drug: Piperaquine and artesunate-pyronaridine (Pyramax)
Drug: Piperaquine · Drug: Artesunate-pyronaridine (Pyramax) · Drug: Piperaquine and artesunate-pyronaridine (Pyramax)
Drug: Piperaquine · Drug: Artesunate-pyronaridine (Pyramax) · Drug: Piperaquine and artesunate-pyronaridine (Pyramax)
Drug: Piperaquine · Drug: Artesunate-pyronaridine (Pyramax) · Drug: Piperaquine and artesunate-pyronaridine (Pyramax)
Drug: Piperaquine · Drug: Artesunate-pyronaridine (Pyramax) · Drug: Piperaquine and artesunate-pyronaridine (Pyramax)
Piperaquine is an antimalarial medicine normally combined with an artemisinin derivative in the combination therapy dihydroartemisinin-piperaquine.
Artesunate-pyronaridine is a medicine that contains the active substances pyronaridine tetraphosphate and artesunate.
Piperaquine is an antimalarial medicine. Artesunate-pyronaridine is a medicine that contains the active substances pyronaridine tetraphosphate and artesunate.
Number of adverse events
Adverse events will be assessed as one of safety and tolerability parameters.
Time frame: Approximately 6 months
Number of events concerning of abnormal electrocardiographic
Electrocardiographic changes especially QTc interval prolongation will be assessed as one of safety and tolerability parameters.
Time frame: Approximately 6 months
Number of events concerning of abnormal vital signs
Abnormal vital signs will be assessed as one of safety and tolerability parameters.
Time frame: Approximately 6 months
Number of events concerning of abnormal laboratory values
Abnormal laboratory values will be assessed as one of safety and tolerability parameters.
Time frame: Approximately 6 months
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.
Time frame: Approximately 6 months
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.
Time frame: Approximately 6 months
Maximum concentration (Cmax)
Maximum concentration (Cmax) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Time frame: Approximately 6 months
Elimination clearance (CL/F)
Elimination clearance (CL/F) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Time frame: Approximately 6 months
Terminal elimination half-life (t1/2)
Terminal elimination half-life (t1/2) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Time frame: Approximately 6 months
Apparent volume of distribution (Vd)
Apparent volume of distribution (Vd) of piperaquine, pyronaridine and artesunate and their metabolites when given alone and in combination.
Time frame: Approximately 6 months
Plan to share: Yes — With participant's consent, participant's clinical data and results from blood analyses stored in our database may be shared with other researchers to use in the future in accordance with the current Data Sharing Policy. However, the other researchers will not be given any information that could identify the participant.
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 64 non-industry phase 1 interventional studies under Malaria, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 24. This study's planned 12 months is close to that.
Counting every sponsor, half of 93 studies reached it within 13 months; a quarter within 7 and three quarters within 20.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Piperaquine