A Phase 2 interventional study of KAE609 and SoC (Coartem) in Uncomplicated Plasmodium Falciparum Malaria, sponsored by Novartis Pharmaceuticals. Completed at 3 sites in 3 countries. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
This was Cohort B2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
The Cohort B2 of this Platfom study (NCT05750628) was the open-label, randomized, two-arm combination therapy evaluating a single oral dose of up to three anti-malarial agents as a loose combination vs. standard of care (SoC), Coartem in adult and adolescent participants.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 60 is below the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
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.
Exclusion Criteria:
Known liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:
History or current diagnosis of abnormalities indicating significant risk of safety for patients participating in the study such as:
Other protocol-defined inclusion/exclusion criteria may apply.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
KLU156 \[(400 mg KAF156, 480 mg Lumefantrine (LUM)-solid dispersion formulation (SDF)\] + KAE609 75 mg was administered orally with light meal as a single dose.
Drug: KAE609 · Drug: KLU156
Artemether 80 mg + lumefantrine 480 mg was administered twice a day for 3 days with a standard meal or drink rich in fat within 30 min of dosing, as per label.
Drug: SoC (Coartem)
oral capsules administered in combination with KLU156
Also known as: Cipargamin
Standard of Care
Also known as: Coartem
oral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609)
Also known as: ganaplacide + lumefantrine solid dispersion formulation
Polymerase Chain Reaction (PCR) Corrected Adequate Clinical and Parasitological Response (ACPR)
ACPR is defined as absence of parasitaemia (PS) on Study Day 29 regardless of axillary temperature, in patients who have not previously met any of the criteria of Early Treatment Failure (ETF), Late Clinical Failure (LCF), or Late Parasitological Failure (LPF). A patient was considered as PCR-corrected ACPR at Day 29 when the patient did not meet any of the criteria of ETF (up to Day 4), LCF (Day 5 to Day 29), or LPF (Day 8 to Day 29), and was absence of PS on Day 29, unless the presence of PS detected after 7 days (Day 8 or later) was due to reinfection. The presence of PS after 7 days of treatment initiation was considered as a reinfection only when the PS had cleared before Day 8, and none of the parasite strain(s) detected on or after Day 8 matched with the parasite strain at baseline.
Time frame: Day 29
Parasite Clearance Time (PCT)
PCT is defined as time after administration of study drug until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. PCT was calculated using the Kaplan-Meier method.
Time frame: up to Day 7
PCR Uncorrected Adequate Clinical and Parasitological Response (ACPR)
ACPR is defined as absence of parasitaemia (PS) on Study Day 29 regardless of axillary temperature, in patients who have not previously met any of the criteria of Early Treatment Failure (ETF), Late Clinical Failure (LCF), or Late Parasitological Failure (LPF). Treatment failures after 7 days due to reinfection were considered as failure for PCR- uncorrected analyses.
Time frame: Day 29
Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum (peak) observed plasma concentration of the drug after dose administration. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax is the time to reach maximum (peak) of the drug plasma concentration after single-dose administration (time). Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Area Under Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h)
The AUC from time zero to the 24-hour postdose sampling time. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours post dose.
Area Under Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48h)
The AUC from time zero to the 48-hour postdose sampling time. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Area Under Plasma Concentration-time Curve (AUClast)
AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of the drug. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.
Area Under Plasma Concentration-time Curve (AUC[0-inf])
AUC\[0-inf\] is the area under the plasma concentration-time curve from time zero extrapolated to infinity. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨. PK parameters derived from AUCinf (AUCinf, CL/F and Vz/F) cannot be reported for patients for whom the extrapolated area under the curve (AUCextrapolated) is more than 20%.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.
Terminal Elimination Half-life (T1/2)
T1/2 is the elimination half-life associated with the terminal slope. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.
Apparent Clearance (CL/F)
CL/F is the apparent total body clearance of the drug from plasma following extravascular administration. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨. PK parameters derived from AUCinf (AUCinf, CL/F and Vz/F) cannot be reported for patients for whom the extrapolated area under the curve (AUCextrapolated) is more than 20%.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F)
Vz/F is the apparent volume of distribution during terminal elimination phase following extravascular administration of the drug. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨. PK parameters derived from AUCinf (AUCinf, CL/F and Vz/F) cannot be reported for patients for whom the extrapolated area under the curve (AUCextrapolated) is more than 20%.
Time frame: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.
Participants took part in 3 investigative sites in 3 countries.
| Milestone | KLU156 400/480 mg + KAE609 75 mg | Artemether 80 mg + Lumefantrine 480 mg |
|---|---|---|
| Started | 30 | 30 |
| Completed | 29 | 29 |
| Not completed | 1 | 1 |
| Withdrew: Guardian decision | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
ACPR is defined as absence of parasitaemia (PS) on Study Day 29 regardless of axillary temperature, in patients who have not previously met any of the criteria of Early Treatment Failure (ETF), Late Clinical Failure (LCF), or Late Parasitological Failure (LPF). A patient was considered as PCR-corrected ACPR at Day 29 when the patient did not meet any of the criteria of ETF (up to Day 4), LCF (Day 5 to Day 29), or LPF (Day 8 to Day 29), and was absence of PS on Day 29, unless the presence of PS detected after 7 days (Day 8 or later) was due to reinfection. The presence of PS after 7 days of treatment initiation was considered as a reinfection only when the PS had cleared before Day 8, and none of the parasite strain(s) detected on or after Day 8 matched with the parasite strain at baseline.
| Percentage of participants | KLU156 400/480 mg + KAE609 75 mg | Artemether 80 mg + Lumefantrine 480 mg |
|---|---|---|
| Polymerase Chain Reaction (PCR) Corrected Adequate Clinical and Parasitological Response (ACPR) | 96.43 (81.65 to 99.91) | 96.67 (82.78 to 99.92) |
PCT is defined as time after administration of study drug until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. PCT was calculated using the Kaplan-Meier method.
| hours | KLU156 400/480 mg + KAE609 75 mg | Artemether 80 mg + Lumefantrine 480 mg |
|---|---|---|
| Parasite Clearance Time (PCT) | 12.1 (8.0 to 16.0) | 47.7 (23.9 to 48.1) |
ACPR is defined as absence of parasitaemia (PS) on Study Day 29 regardless of axillary temperature, in patients who have not previously met any of the criteria of Early Treatment Failure (ETF), Late Clinical Failure (LCF), or Late Parasitological Failure (LPF). Treatment failures after 7 days due to reinfection were considered as failure for PCR- uncorrected analyses.
| Percentage of participants | KLU156 400/480 mg + KAE609 75 mg | Artemether 80 mg + Lumefantrine 480 mg |
|---|---|---|
| PCR Uncorrected Adequate Clinical and Parasitological Response (ACPR) | 86.67 (69.28 to 96.24) | 93.33 (77.93 to 99.18) |
Cmax is the maximum (peak) observed plasma concentration of the drug after dose administration. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
| ng/mL | KLU156 400/480 mg + KAE609 75 mg |
|---|---|
| cipargamin (KAE609) | 1150 ± 59.7 |
| ganaplacide (KAF156) | 804 ± 39.4 |
| lumefantrine | 8280 ± 131.4 |
Tmax is the time to reach maximum (peak) of the drug plasma concentration after single-dose administration (time). Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
| hours | KLU156 400/480 mg + KAE609 75 mg |
|---|---|
| cipargamin (KAE609) | 8.03 (2.08 to 12.3) |
| ganaplacide (KAF156) | 4.08 (1.08 to 8.18) |
| lumefantrine | 8.11 (3.80 to 24.0) |
The AUC from time zero to the 24-hour postdose sampling time. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
| h*ng/mL | KLU156 400/480 mg + KAE609 75 mg |
|---|---|
| cipargamin (KAE609) | 18600 ± 63.3 |
| ganaplacide (KAF156) | 10800 ± 43.9 |
| lumefantrine | 126000 ± 128.5 |
The AUC from time zero to the 48-hour postdose sampling time. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
| h*ng/mL | KLU156 400/480 mg + KAE609 75 mg |
|---|---|
| cipargamin (KAE609) | 31300 ± 66.2 |
| ganaplacide (KAF156) | 16100 ± 46.5 |
| lumefantrine | 199000 ± 113.8 |
AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of the drug. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
| h*ng/mL | KLU156 400/480 mg + KAE609 75 mg |
|---|---|
| cipargamin (KAE609) | 45200 ± 75.5 |
| ganaplacide (KAF156) | 21800 ± 53.0 |
| lumefantrine | 270000 ± 117.7 |
AUC\[0-inf\] is the area under the plasma concentration-time curve from time zero extrapolated to infinity. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨. PK parameters derived from AUCinf (AUCinf, CL/F and Vz/F) cannot be reported for patients for whom the extrapolated area under the curve (AUCextrapolated) is more than 20%.
| h*ng/mL | KLU156 400/480 mg + KAE609 75 mg |
|---|---|
| cipargamin (KAE609) | 49700 ± 63.5 |
| ganaplacide (KAF156) | 23200 ± 52.8 |
| lumefantrine | 326000 ± 77.0 |
T1/2 is the elimination half-life associated with the terminal slope. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨.
| hours | KLU156 400/480 mg + KAE609 75 mg |
|---|---|
| cipargamin (KAE609) | 22.7 ± 48.5 |
| ganaplacide (KAF156) | 28.1 ± 32.3 |
| lumefantrine | 40.9 ± 27.8 |
CL/F is the apparent total body clearance of the drug from plasma following extravascular administration. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨. PK parameters derived from AUCinf (AUCinf, CL/F and Vz/F) cannot be reported for patients for whom the extrapolated area under the curve (AUCextrapolated) is more than 20%.
| mL/h | KLU156 400/480 mg + KAE609 75 mg |
|---|---|
| cipargamin (KAE609) | 1510 ± 63.5 |
| ganaplacide (KAF156) | 17200 ± 52.8 |
| lumefantrine | 1470 ± 77.0 |
Vz/F is the apparent volume of distribution during terminal elimination phase following extravascular administration of the drug. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 6.4 or higher). The drug concentration was determined by a validated LC-MS/MS method. Concentrations were expressed in mass per volume units and referred to the free base. Concentrations below the lower limit of quantification (LLOQ) were reported as "zero¨. PK parameters derived from AUCinf (AUCinf, CL/F and Vz/F) cannot be reported for patients for whom the extrapolated area under the curve (AUCextrapolated) is more than 20%.
| mL | KLU156 400/480 mg + KAE609 75 mg |
|---|---|
| cipargamin (KAE609) | 47200 ± 64.8 |
| ganaplacide (KAF156) | 688000 ± 51.1 |
| lumefantrine | 88000 ± 69.5 |
Collected over Adverse events were reported up to approximately 43 days after administration of study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KLU156 400/480 mg + KAE609 75 mg | 0/30 (0%) | 0/30 (0%) | 20/30 (66.7%) |
| Artemether 80 mg + Lumefantrine 480 mg | 0/30 (0%) | 0/30 (0%) | 12/30 (40%) |
| Total | 0/60 (0%) | 0/60 (0%) | 32/60 (53.3%) |
| Event | KLU156 400/480 mg + KAE609 75 mg | Artemether 80 mg + Lumefantrine 480 mg | Total |
|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 8/30 | 2/30 | 10/60 |
| VomitingGastrointestinal disorders | 8/30 | 1/30 | 9/60 |
| MalariaInfections and infestations | 7/30 | 5/30 | 12/60 |
| HeadacheNervous system disorders | 2/30 | 4/30 | 6/60 |
| PyrexiaGeneral disorders | 2/30 | 3/30 | 5/60 |
| ChillsGeneral disorders | 1/30 | 2/30 | 3/60 |
| PharyngitisInfections and infestations | 0/30 | 2/30 | 2/60 |
| Upper respiratory tract infectionInfections and infestations | 2/30 | 2/30 | 4/60 |
| Soft tissue injuryInjury, poisoning and procedural complications | 2/30 | 1/30 | 3/60 |
| Age, Continuous(years) | KLU156 400/480 mg + KAE609 75 mg | Artemether 80 mg + Lumefantrine 480 mg | Total |
|---|---|---|---|
| Mean | 20.2 ± 8.64 | 19.9 ± 8.18 | 20.1 ± 8.34 |
| Sex: Female, Male(Participants) | KLU156 400/480 mg + KAE609 75 mg | Artemether 80 mg + Lumefantrine 480 mg | Total |
|---|---|---|---|
| Female | 20 | 13 | 33 |
| Male | 10 | 17 | 27 |
| Race/Ethnicity, Customized(Participants) | KLU156 400/480 mg + KAE609 75 mg | Artemether 80 mg + Lumefantrine 480 mg | Total |
|---|---|---|---|
| Black or African American | 30 | 29 | 59 |
| Multiple | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Studies of the drugs tested here: NITD 609 · KLU156