Trial Outcomes & Findings for Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2) (NCT NCT07235033)
NCT ID: NCT07235033
Last Updated: 2026-05-07
Results Overview
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.
COMPLETED
PHASE2
60 participants
Day 29
2026-05-07
Participant Flow
Participants took part in 3 investigative sites in 3 countries.
The study consisted of a screening period from -6h to 0h to assess eligibility.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Guardian Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)
Baseline characteristics by cohort
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=30 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
Artemether 80 mg + Lumefantrine 480 mg
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.2 years
STANDARD_DEVIATION 8.64 • n=54 Participants
|
19.9 years
STANDARD_DEVIATION 8.18 • n=60 Participants
|
20.1 years
STANDARD_DEVIATION 8.34 • n=114 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=54 Participants
|
13 Participants
n=60 Participants
|
33 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=54 Participants
|
17 Participants
n=60 Participants
|
27 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
30 Participants
n=54 Participants
|
29 Participants
n=60 Participants
|
59 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: 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.
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.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=28 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
Artemether 80 mg + Lumefantrine 480 mg
n=30 Participants
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.
|
|---|---|---|
|
Polymerase Chain Reaction (PCR) Corrected Adequate Clinical and Parasitological Response (ACPR)
|
96.43 Percentage of participants
Interval 81.65 to 99.91
|
96.67 Percentage of participants
Interval 82.78 to 99.92
|
SECONDARY outcome
Timeframe: up to Day 7Population: 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.
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.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=30 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
Artemether 80 mg + Lumefantrine 480 mg
n=30 Participants
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.
|
|---|---|---|
|
Parasite Clearance Time (PCT)
|
12.1 hours
Interval 8.0 to 16.0
|
47.7 hours
Interval 23.9 to 48.1
|
SECONDARY outcome
Timeframe: Day 29Population: 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.
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.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=30 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
Artemether 80 mg + Lumefantrine 480 mg
n=30 Participants
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.
|
|---|---|---|
|
PCR Uncorrected Adequate Clinical and Parasitological Response (ACPR)
|
86.67 Percentage of participants
Interval 69.28 to 96.24
|
93.33 Percentage of participants
Interval 77.93 to 99.18
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.Population: 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.
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¨.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=29 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
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.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
cipargamin (KAE609)
|
1150 ng/mL
Geometric Coefficient of Variation 59.7
|
—
|
|
Maximum Observed Plasma Concentration (Cmax)
ganaplacide (KAF156)
|
804 ng/mL
Geometric Coefficient of Variation 39.4
|
—
|
|
Maximum Observed Plasma Concentration (Cmax)
lumefantrine
|
8280 ng/mL
Geometric Coefficient of Variation 131.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.Population: 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.
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¨.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=29 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
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.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
ganaplacide (KAF156)
|
4.08 hours
Interval 1.08 to 8.18
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
cipargamin (KAE609)
|
8.03 hours
Interval 2.08 to 12.3
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
lumefantrine
|
8.11 hours
Interval 3.8 to 24.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, and 24 hours post dose.Population: 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.
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¨.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=29 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
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.
|
|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h)
cipargamin (KAE609)
|
18600 h*ng/mL
Geometric Coefficient of Variation 63.3
|
—
|
|
Area Under Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h)
ganaplacide (KAF156)
|
10800 h*ng/mL
Geometric Coefficient of Variation 43.9
|
—
|
|
Area Under Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h)
lumefantrine
|
126000 h*ng/mL
Geometric Coefficient of Variation 128.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.Population: 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.
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¨.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=29 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
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.
|
|---|---|---|
|
Area Under Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48h)
lumefantrine
|
199000 h*ng/mL
Geometric Coefficient of Variation 113.8
|
—
|
|
Area Under Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48h)
cipargamin (KAE609)
|
31300 h*ng/mL
Geometric Coefficient of Variation 66.2
|
—
|
|
Area Under Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48h)
ganaplacide (KAF156)
|
16100 h*ng/mL
Geometric Coefficient of Variation 46.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.Population: 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.
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¨.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=29 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
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.
|
|---|---|---|
|
Area Under Plasma Concentration-time Curve (AUClast)
cipargamin (KAE609)
|
45200 h*ng/mL
Geometric Coefficient of Variation 75.5
|
—
|
|
Area Under Plasma Concentration-time Curve (AUClast)
ganaplacide (KAF156)
|
21800 h*ng/mL
Geometric Coefficient of Variation 53.0
|
—
|
|
Area Under Plasma Concentration-time Curve (AUClast)
lumefantrine
|
270000 h*ng/mL
Geometric Coefficient of Variation 117.7
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.Population: 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.
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%.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=28 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
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.
|
|---|---|---|
|
Area Under Plasma Concentration-time Curve (AUC[0-inf])
cipargamin (KAE609)
|
49700 h*ng/mL
Geometric Coefficient of Variation 63.5
|
—
|
|
Area Under Plasma Concentration-time Curve (AUC[0-inf])
ganaplacide (KAF156)
|
23200 h*ng/mL
Geometric Coefficient of Variation 52.8
|
—
|
|
Area Under Plasma Concentration-time Curve (AUC[0-inf])
lumefantrine
|
326000 h*ng/mL
Geometric Coefficient of Variation 77.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 168 hours post dose.Population: 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.
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¨.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=29 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
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.
|
|---|---|---|
|
Terminal Elimination Half-life (T1/2)
lumefantrine
|
40.9 hours
Geometric Coefficient of Variation 27.8
|
—
|
|
Terminal Elimination Half-life (T1/2)
cipargamin (KAE609)
|
22.7 hours
Geometric Coefficient of Variation 48.5
|
—
|
|
Terminal Elimination Half-life (T1/2)
ganaplacide (KAF156)
|
28.1 hours
Geometric Coefficient of Variation 32.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.Population: 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.
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%.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=28 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
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.
|
|---|---|---|
|
Apparent Clearance (CL/F)
cipargamin (KAE609)
|
1510 mL/h
Geometric Coefficient of Variation 63.5
|
—
|
|
Apparent Clearance (CL/F)
ganaplacide (KAF156)
|
17200 mL/h
Geometric Coefficient of Variation 52.8
|
—
|
|
Apparent Clearance (CL/F)
lumefantrine
|
1470 mL/h
Geometric Coefficient of Variation 77.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 4, 6, 8, 12, 24, and 48 hours post dose.Population: 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.
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%.
Outcome measures
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=28 Participants
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
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.
|
|---|---|---|
|
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F)
ganaplacide (KAF156)
|
688000 mL
Geometric Coefficient of Variation 51.1
|
—
|
|
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F)
cipargamin (KAE609)
|
47200 mL
Geometric Coefficient of Variation 64.8
|
—
|
|
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F)
lumefantrine
|
88000 mL
Geometric Coefficient of Variation 69.5
|
—
|
Adverse Events
KLU156 400/480 mg + KAE609 75 mg
Artemether 80 mg + Lumefantrine 480 mg
Total
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
KLU156 400/480 mg + KAE609 75 mg
n=30 participants at risk
KLU156 (400 mg KAF156, 480 mg lumefantrine-SDF) + KAE609 75 mg was administered orally with light meal as a single dose.
|
Artemether 80 mg + Lumefantrine 480 mg
n=30 participants at risk
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.
|
Total
n=60 participants at risk
Total
|
|---|---|---|---|
|
Infections and infestations
Malaria
|
23.3%
7/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
16.7%
5/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
20.0%
12/60 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
6.7%
2/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
3.3%
2/60 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
2/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
6.7%
2/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
6.7%
4/60 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
6.7%
2/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
3.3%
1/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
5.0%
3/60 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
|
Nervous system disorders
Headache
|
6.7%
2/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
13.3%
4/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
10.0%
6/60 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
26.7%
8/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
6.7%
2/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
16.7%
10/60 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
8/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
3.3%
1/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
15.0%
9/60 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
|
General disorders
Chills
|
3.3%
1/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
6.7%
2/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
5.0%
3/60 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
|
General disorders
Pyrexia
|
6.7%
2/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
10.0%
3/30 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
8.3%
5/60 • Adverse events were reported up to approximately 43 days after administration of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER