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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort B2: KLU156 400/480 mg + KAE609 75 mg | Experimental | 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. |
|
| Cohort B2: SoC (Artemether 80 mg + lumefantrine 480 mg) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAE609 | Drug | oral capsules administered in combination with KLU156 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to Day 7 |
| PCR Uncorrected Adequate Clinical and Parasitological Response (ACPR) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening
Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level < 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening
Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B 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:
Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.
Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of effective contraception, and sexually active patients not willing to practice effective contraception.
History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Abidjan | 13BP972 | Côte d’Ivoire | |||
| Novartis Investigative Site |
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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The study consisted of a screening period from -6h to 0h to assess eligibility.
Participants took part in 3 investigative sites in 3 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | KLU156 400/480 mg + KAE609 75 mg | KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose. |
| FG001 | Artemether 80 mg + Lumefantrine 480 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2023 | Feb 20, 2026 |
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This study was open-label, but Core Clinical Team is blinded to treatment information.
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| SoC (Coartem) | Drug | Standard of Care |
|
|
| KLU156 | Drug | oral sachet formulation (KAF156+LUM-SDF) administered in combination with cipargamin (KAE609) |
|
|
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. |
| 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¨. | 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¨. | 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¨. | 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¨. | 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¨. | 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%. | 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¨. | 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%. | 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%. | Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose. |
| Libreville |
| BP 1437 |
| Gabon |
| Novartis Investigative Site | Ahero | 40100 | Kenya |
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.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | KLU156 400/480 mg + KAE609 75 mg | KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose. |
| BG001 | Artemether 80 mg + Lumefantrine 480 mg | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Principal stratum, excluding participants for whom any of the following events were observed: (1) receiving concomitant medication with anti-malarial activity prior to Day 29 for reasons other than rescue therapy for recrudescence, (2) missing a PCR genotyping assessment at baseline and having re-appearance of parasites prior to Day 29, and (3) not fully dosed. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 29 |
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| Secondary | 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. | Full analysis set (FAS): the FAS comprised all patients that have baseline P. falciparum count > 0 and take at least one dose of the study treatment during the treatment period. Following the intent-to-treat principle, patients were analyzed according to the treatment group assigned at randomization. | Posted | Median | 90% Confidence Interval | hours | up to Day 7 |
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| Secondary | 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. | Full analysis set (FAS): the FAS comprised all patients that have baseline P. falciparum count > 0 and take at least one dose of the study treatment during the treatment period. Following the intent-to-treat principle, patients were analyzed according to the treatment group assigned at randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 29 |
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| Secondary | 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¨. | Pharmacokinetic (PK) analysis set: All patients who had at least one valid (i.e., not flagged for exclusion) PK concentration measurement, received at least one dose of KLU156 400/480 mg + KAE609 75 mg, and did not have any protocol deviations that impacted PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose. |
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| Secondary | 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¨. | Pharmacokinetic (PK) analysis set: All patients who had at least one valid (i.e., not flagged for exclusion) PK concentration measurement, received at least one dose of KLU156 400/480 mg + KAE609 75 mg, and did not have any protocol deviations that impacted PK data. | Posted | Median | Full Range | hours | Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose. |
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| Secondary | 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¨. | Pharmacokinetic (PK) analysis set: All patients who had at least one valid (i.e., not flagged for exclusion) PK concentration measurement, received at least one dose of KLU156 400/480 mg + KAE609 75 mg, and did not have any protocol deviations that impacted PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours post dose. |
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| Secondary | 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¨. | Pharmacokinetic (PK) analysis set: All patients who had at least one valid (i.e., not flagged for exclusion) PK concentration measurement, received at least one dose of KLU156 400/480 mg + KAE609 75 mg, and did not have any protocol deviations that impacted PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose. |
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| Secondary | 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¨. | Pharmacokinetic (PK) analysis set: All patients who had at least one valid (i.e., not flagged for exclusion) PK concentration measurement, received at least one dose of KLU156 400/480 mg + KAE609 75 mg, and did not have any protocol deviations that impacted PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose. |
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| Secondary | 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%. | Pharmacokinetic (PK) analysis set: All patients who had at least one valid (i.e., not flagged for exclusion) PK concentration measurement, received at least one dose of KLU156 400/480 mg + KAE609 75 mg, and did not have any protocol deviations that impacted PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose. |
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| Secondary | 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¨. | Pharmacokinetic (PK) analysis set: All patients who had at least one valid (i.e., not flagged for exclusion) PK concentration measurement, received at least one dose of KLU156 400/480 mg + KAE609 75 mg, and did not have any protocol deviations that impacted PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose. |
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| Secondary | 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%. | Pharmacokinetic (PK) analysis set: All patients who had at least one valid (i.e., not flagged for exclusion) PK concentration measurement, received at least one dose of KLU156 400/480 mg + KAE609 75 mg, and did not have any protocol deviations that impacted PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/h | Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose. |
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| Secondary | 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%. | Pharmacokinetic (PK) analysis set: All patients who had at least one valid (i.e., not flagged for exclusion) PK concentration measurement, received at least one dose of KLU156 400/480 mg + KAE609 75 mg, and did not have any protocol deviations that impacted PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL | Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose. |
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Adverse events were reported up to approximately 43 days after administration of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KLU156 400/480 mg + KAE609 75 mg | KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose. | 0 | 30 | 0 | 30 | 20 | 30 |
| EG001 | Artemether 80 mg + Lumefantrine 480 mg | 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. | 0 | 30 | 0 | 30 | 12 | 30 |
| EG002 | Total | Total | 0 | 60 | 0 | 60 | 32 | 60 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (28.0) | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (28.0) | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA (28.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (28.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2025 | Feb 20, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
Not provided
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| ID | Term |
|---|---|
| C552304 | NITD 609 |
| D000077611 | Artemether, Lumefantrine Drug Combination |
| C000599914 | ganaplacide |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Multiple |
|
Probability that the combined therapy is non-inferior to SoC such that the treatment difference (SoC-KLU156 + cipargamin) is less than 10%. |
| Bayesian analysis |
| probability (%) treatment diff. < 10% |
| 100 |
| Non-Inferiority |
For clinical relevance, non-inferiority if > 50% probability that treatment difference is less than 10%. |
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| Participants |
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