A Phase 2 interventional study of Cipargamin and IV Artesunate in Severe Malaria, sponsored by Novartis Pharmaceuticals. Completed at 9 sites in 7 countries. Open to participants aged 6 Months to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
The purpose of this study was to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria.
The study also intended to evaluate clinical treatment success using a novel clinical endpoint for drug development in severe malaria.
Severe malaria is a medical emergency and is affecting primarily young children in Africa. Injectable artesunate is the standard of care for the treatment of severe malaria and is highly efficacious. However, the spread of artemisinin-resistance in Plasmodium falciparum in Asian countries poses a threat for future treatment of patients with this life-threatening disease. To mitigate this risk, there is a need for another drug in malaria-endemic countries. Cipargamin treatment results in rapid clearance of parasites, including artemisinin-resistant parasites.
This study was an adaptive, multicenter, randomized, open label, sequential cohort study in participants aged ≥12 years old in Cohorts 1-2 and \<12 years old to ≥6 months in Cohorts 3-5 with a diagnosis of moderately severe (Cohort 1) and severe P. falciparum malaria (Cohorts 2-5). This study investigated the efficacy (parasite reduction and clinical outcome), safety, tolerability, and pharmacokinetics (PK) of different intravenous (IV) dose regimens of cipargamin in comparison to IV artesunate.
Cohorts 1 and 2:
Participants were randomized to one of three treatment arms in a 1:1:1 ratio: two cipargamin-based treatment arms with dose levels of 20 mg and 40 mg, and the control arm with IV artesunate, a standard of care. The analysis of results from Cohorts 1 and 2 was planned to be used to determine the safe and efficacious exposure range and the corresponding dose (in a weight-adjusted manner) for the participants in Cohorts 3 to 5.
Cohorts 3 to 5:
Participants were randomized to 40 mg of cipargamin administered in a dose-adjusted manner and standard dose of IV artesunate in 1:1 ratio.
In all cohorts, participants in IV cipargamin arms were treated once daily for at least 24 hours (2 doses at 0 and 24 hour timepoints) and a maximum of 48 hours (3 doses at 0, 24, and 48 hour timepoints) and with IV artesunate as rescue medication. Participants in the IV artesunate arm received IV artesunate for at least 24 hours (3 doses at 0, 12, and 24 hours timepoints) and for a maximum of 8 doses (7 days), if necessary. Participants in all arms received Coartem twice daily (b.i.d.) for 3 days following IV therapy. The study was conducted in a hospital setting, and participants were followed up until Day 29.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 254 is close to the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria 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.
Inclusion Criteria:
Cohort 1: Participants aged ≥ 12 years with moderately severe malaria as defined in (prostration and/or repeated vomiting) without presence of other signs of severe malaria (and with high P. falciparum parasitemia (60,000-250,000 parasites per µl)
Exclusion Criteria:
Exclusion criteria applying to all Cohorts 1 to 5:
Signs/symptoms of severe malnutrition in general accordance with WHO guidelines:
Known underlying illness, surgical or medical condition, which is not related to ongoing event of severe malaria and which might jeopardize the participant's health in case of participation in the study or which might alter the distribution, metabolism or excretion of study treatment. For example:
Additional exclusion criteria are as follows:
Exclusion criteria for Cohort 1:
Exclusion criteria for Cohort 2:
Exclusion criteria for Cohorts 3 to 5:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Participants received intravenous cipargamin 20 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
Drug: Cipargamin · Drug: Coartem
Participants received intravenous cipargamin 40 mg, as a minimum of two doses every 24 hours, not exceeding 3 doses followed by oral medication (Coartem®, twice daily \[b.i.d.\] for 3 days).
Drug: Cipargamin · Drug: Coartem
Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days).
Drug: IV Artesunate · Drug: Coartem
Cipargamin, 20 mg or 40 mg, by intravenous administration of solution for injection
Also known as: KAE609
Artesunate, 2.4 mg/kg or 3 mg/kg, by intravenous administration of reconstituted solution
Also known as: Artesunate
Oral standard of care (Coartem tablets, dosed per weight, as per label)
Also known as: Artemether, Lumefantrine
Percentage of Participants Achieving at Least 90% Reduction in Plasmodium Falciparum (P. Falciparum) at 12 Hours
A blood draw was performed at each collection time point for parasitemia assessment.
Time frame: 12 Hours
Percentage of Participants Achieving Clinical Success at 48 Hours
Clinical success was a composite endpoint based on following criteria: 1. Was participant dead or alive 2. Presence of asexual parasites (yes/no) 3. Presence of any of the key signs of severe malaria (yes/no)
Time frame: 48 Hours
Percentage of Participants With Individual Signs of Severe Malaria Over Time
Individual signs of severe malaria over time were monitored for the presence of the following signs of severe malaria during the entire study duration: 1. Altered consciousness - Prostration or GCS \< 11 for participants \> 5 years / BCS \< 3 for participants =\< 5 years of age 2. Renal Impairment - Serum creatinine \> 3xULN or \> 3 mg/dL or need for renal replacement therapy 3. Acidosis - Serum lactate \> 4 mmol/L 4. Respiratory distress - present or absent 5. Severe anemia - Hb \< 5 g/dl or Hb \< 7g/dl in pediatric and adults respectively or need of blood transfusion 6. Jaundice - Serum bilirubin \> 3 g/dl 7. Hypoglycemia- plasma glucose \< 40 mg/dL
Time frame: Baseline to Day 29
Percentage of Participants Developing Hemolysis (Early and Delayed) After Treatment
Development (early and delayed) of hemolysis after treatments was defined as follows: Early Hemolytic anemia was defined as 10% or greater decrease in hemoglobin levels and an increase of lactate dehydrogenase (LDH) levels to \>390 U/L, or an increase of \>= 10% above baseline occurring up to Day 8 of the study. Delayed hemolytic anemia occurred \> 7 days after initiation of parenteral study drug (IV artesunate or IV cipargamin) during the study period. The event was characterized by a 10% or greater decrease in hemoglobin levels accompanied by increase of LDH levels to \>390 U/L, or an increase of \>= 10% compared to the values measured at Day 8 of the study.
Time frame: Day 8 and Day 29
Percentage of Participants With Neurological Sequelae at Day 29
Detailed neurological examination was conducted and relevant medical history collected to assess the extent of neurological signs and symptoms at baseline and to monitor the extent of neurological sequelae in follow-up visits.
Time frame: Day 29
Percentage of Participants Achieving at Least 90% Reduction in Plasmodium Falciparum (P. Falciparum)
A blood draw was performed at each collection time point for parasitemia assessment.
Time frame: 24 hours and 48 hours
Time to Parasite Clearance (PCT)
Parasite clearance time (PCT) was defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 24 hours.
Time frame: Up to 72 hours
Parasite Clearance Estimator (PCE) Slope Half-life
Slope half-life (hours) for parasite clearance was calculated for each patient using the WWARN (World Wide Antimalarial Resistance Network) Parasite Clearance Estimator.
Time frame: Up to 72 hours
Time to Fever Clearance (FCT)
Fever clearance time (FCT) was defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours.
Time frame: Up to 72 hours
P. Falciparum Parasite Reduction Ratios (PRR) at 12, 24 and 48 Hours
PRR was defined as the ratio of asexual parasite at baseline divided by asexual parasite at post-baseline. If the asexual parasite count at post-baseline was 0, the half value of detection limit was used to calculate the ratio.
Time frame: 12 hours, 24 hours, and 48 hours
Percentage of Participants With Recrudescence and Reinfection
Recrudescence was defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Reinfection was defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. Reinfection and Recrudescence were confirmed by polymerase chain reaction (PCR) analysis.
Time frame: Day 29
Time to Switch to Oral Therapy
Time to switch participants from IV therapy to Coartem (standard of drug for oral therapy) was analyzed.
Time frame: Day 3 to Day 29
Time to Discharge From Hospital
Time frame: Day 3 to Day 29
Time to Recover From Prostration
To assess recovery of participants as measured by time to recovery from prostration compared to baseline.
Time frame: Day 1 to Day 29
Number of Participants With Adverse Events or Serious Adverse Events, or Who Died
Adverse events (AEs) and serious adverse events (SAEs) were collected from first dosing. Death routine laboratory assessments were assessed up to last follow-up visit or until the event had resolved to baseline grade or better, or the event was assessed stable by the investigator, or the participant was lost to follow-up or withdrew consent.
Time frame: Day 1 to Day 29
Observed Maximum Plasma Concentration (Cmax) of IV Cipargamin
Blood samples were collected for pharmacokinetics characterization. Cmax is the maximum (peak) observed plasma concentration of cipargamin after dose administration. Cmax was listed and summarized using descriptive statistics.
Time frame: Day 1 - Day 8
Time of Maximum Observed Drug Concentration Occurrence (Tmax) of IV Cipargamin
Blood samples were collected for pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics. Time to reach maximum observed plasma concentration of cipargamin after dose administration.
Time frame: Day 1 - Day 8
Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of IV Cipargamin
Blood samples were collected for pharmacokinetics characterization. AUClast was listed and summarized using descriptive statistics.
Time frame: Day 1 - Day 8
Area Under the Concentration Time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of IV Cipargamin
Blood samples were collected for pharmacokinetics characterization. AUC(0-inf) post last dose was listed and summarized using descriptive statistics.
Time frame: Day 1 - Day 8
Area Under the Plasma Concentration-time Curve From the Time 0 to 24 Hours (AUC0-24hours) of IV Cipargamin
Blood samples were collected for pharmacokinetics characterization. AUC(0-24h) was listed and summarized using descriptive statistics.
Time frame: Day 1 - Day 8
Terminal Elimination Half Life (T1/2) of IV Cipargamin
Blood samples were collected for pharmacokinetics characterization. The half-life post last dose was summarized using descriptive statistics.
Time frame: Day 1 - Day 8
Total Systemic Clearance for Intravenous Administration (CL) of IV Cipargamin
Blood samples were collected for pharmacokinetics characterization. CL post last dose was summarized using descriptive statistics.
Time frame: Day 1 - Day 8
Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of IV Cipargamin
Blood samples were collected for pharmacokinetics characterization. Vz post last dose was listed and summarized using descriptive statistics.
Time frame: Day 1 - Day 8
| Milestone | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Started | 20 | 116 | 118 |
| Completed | 20 | 114 | 116 |
| Not completed | 0 | 2 | 2 |
| Withdrew: Randomized but not treated | 0 | 2 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
A blood draw was performed at each collection time point for parasitemia assessment.
| percentage of participants | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Percentage of Participants Achieving at Least 90% Reduction in Plasmodium Falciparum (P. Falciparum) at 12 Hours | 80.0 | 93.0 | 39.3 |
Clinical success was a composite endpoint based on following criteria: 1. Was participant dead or alive 2. Presence of asexual parasites (yes/no) 3. Presence of any of the key signs of severe malaria (yes/no)
| percentage of participants | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Percentage of Participants Achieving Clinical Success at 48 Hours | 95.0 (78.4 to 99.7) | 85.1 (78.5 to 90.3) | 74.4 (66.9 to 80.9) |
Individual signs of severe malaria over time were monitored for the presence of the following signs of severe malaria during the entire study duration: 1. Altered consciousness - Prostration or GCS \< 11 for participants \> 5 years / BCS \< 3 for participants =\< 5 years of age 2. Renal Impairment - Serum creatinine \> 3xULN or \> 3 mg/dL or need for renal replacement therapy 3. Acidosis - Serum lactate \> 4 mmol/L 4. Respiratory distress - present or absent 5. Severe anemia - Hb \< 5 g/dl or Hb \< 7g/dl in pediatric and adults respectively or need of blood transfusion 6. Jaundice - Serum bilirubin \> 3 g/dl 7. Hypoglycemia- plasma glucose \< 40 mg/dL
| percentage of participants | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Baseline, at Least One Sign | 95.0 | 98.2 | 100.0 |
| Baseline, at Least Two Signs | 35.0 | 43.9 | 45.3 |
| Baseline, at Least Three Signs | 10.0 | 14.0 | 17.9 |
| Baseline, at Least Four Signs | 0 | 3.5 | 10.3 |
| Baseline, at Least Five Signs | 0 | 0.9 | 4.3 |
| Baseline, at Least Six Signs | 0 | 0 | 0.9 |
| Day 29, at Least One Sign | 5.0 | 6.2 | 7.0 |
Development (early and delayed) of hemolysis after treatments was defined as follows: Early Hemolytic anemia was defined as 10% or greater decrease in hemoglobin levels and an increase of lactate dehydrogenase (LDH) levels to \>390 U/L, or an increase of \>= 10% above baseline occurring up to Day 8 of the study. Delayed hemolytic anemia occurred \> 7 days after initiation of parenteral study drug (IV artesunate or IV cipargamin) during the study period. The event was characterized by a 10% or greater decrease in hemoglobin levels accompanied by increase of LDH levels to \>390 U/L, or an increase of \>= 10% compared to the values measured at Day 8 of the study.
| percentage of participants | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Early Hemolysis | 55.0 | 54.4 | 62.1 |
| Delayed Hemolysis | 5.0 | 3.5 | 3.4 |
Detailed neurological examination was conducted and relevant medical history collected to assess the extent of neurological signs and symptoms at baseline and to monitor the extent of neurological sequelae in follow-up visits.
| percentage of participants | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Speech Impairment | 0 | 0 | 0.9 |
| Hemiplegia or Hemiparesis | 0 | 0 | 0.9 |
A blood draw was performed at each collection time point for parasitemia assessment.
| percentage of participants | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| 24 Hours Post-Dose | 90.0 | 100.0 | 97.4 |
| 48 Hours Post-Dose | 100.0 | 100.0 | 99.1 |
Parasite clearance time (PCT) was defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 24 hours.
| hours | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Time to Parasite Clearance (PCT) | 21.1 (18.0 to 24.8) | 18.0 (12.2 to 18.2) | 36.0 (30.0 to 36.1) |
Slope half-life (hours) for parasite clearance was calculated for each patient using the WWARN (World Wide Antimalarial Resistance Network) Parasite Clearance Estimator.
| hours | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Parasite Clearance Estimator (PCE) Slope Half-life | 1.63 (0.22 to 3.61) | 1.10 (0.27 to 10.03) | 2.21 (0.65 to 10.75) |
Fever clearance time (FCT) was defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours.
| hours | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Time to Fever Clearance (FCT) | 6.2 (6.1 to 18.0) | 6.1 (0.6 to 11.7) | 17.8 (6.1 to 18.0) |
PRR was defined as the ratio of asexual parasite at baseline divided by asexual parasite at post-baseline. If the asexual parasite count at post-baseline was 0, the half value of detection limit was used to calculate the ratio.
| ratio | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| 12 Hours n=20,114,116 | 203.2 (1.4 to 8737.4) | 1347.8 (2.4 to 48092.3) | 7.5 (1.0 to 9582.8) |
| 24 Hours n=20,114,116 | 3772.6 (4.8 to 18744.9) | 4092.5 (25.1 to 48092.3) | 560.6 (4.7 to 25525.9) |
| 48 Hours n=20,113,116 | 6220.5 (560.6 to 31097.8) | 7175.1 (292.0 to 51495.5) | 5509.1 (58.1 to 72470.1) |
Recrudescence was defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Reinfection was defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. Reinfection and Recrudescence were confirmed by polymerase chain reaction (PCR) analysis.
| percentage of participants | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Recrudescence | 0 | 2.7 | 1.8 |
| Reinfection | 0 | 8.0 | 7.9 |
Time to switch participants from IV therapy to Coartem (standard of drug for oral therapy) was analyzed.
| hours | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Time to Switch to Oral Therapy | 43.9 (41.6 to 46.9) | 43.3 (42.3 to 44.2) | 44.4 (43.6 to 44.9) |
| hours | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Time to Discharge From Hospital | 73.2 (73.0 to 73.6) | 73.1 (72.9 to 73.2) | 73.1 (72.9 to 73.1) |
To assess recovery of participants as measured by time to recovery from prostration compared to baseline.
| hours | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| Time to Recover From Prostration | 18.2 (12.3 to 24.4) | 12.4 (12.1 to 18.2) | 18.3 (17.8 to 23.7) |
Adverse events (AEs) and serious adverse events (SAEs) were collected from first dosing. Death routine laboratory assessments were assessed up to last follow-up visit or until the event had resolved to baseline grade or better, or the event was assessed stable by the investigator, or the participant was lost to follow-up or withdrew consent.
| participants | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate |
|---|---|---|---|
| AEs | 12 | 79 | 73 |
| SAEs | 0 | 5 | 4 |
| Deaths | 0 | 0 | 0 |
Blood samples were collected for pharmacokinetics characterization. Cmax is the maximum (peak) observed plasma concentration of cipargamin after dose administration. Cmax was listed and summarized using descriptive statistics.
| ng/mL | IV Cipargamin 20 mg | IV Cipargamin 40 mg |
|---|---|---|
| Dose 1 n=18,55 | 1350 (1150 to 1570) | 3230 (2870 to 3630) |
| Dose 2 n-20,55 | 1390 (1150 to 1690) | 3420 (3020 to 3880) |
| Dose 3 n=3,1 | 1160 (553 to 2430) | 2720 (NA to NA) |
Blood samples were collected for pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics. Time to reach maximum observed plasma concentration of cipargamin after dose administration.
| hours | IV Cipargamin 20 mg | IV Cipargamin 40 mg |
|---|---|---|
| Dose 1 n=18,55 | 0.099 (0.073 to 0.135) | 0.106 (0.089 to 0.125) |
| Dose 2 n=20,55 | 0.221 (0.133 to 0.366) | 0.158 (0.116 to 0.216) |
| Dose 3 n=3,1 | 0.141 (0.007 to 2.79) | 0.05 (NA to NA) |
Blood samples were collected for pharmacokinetics characterization. AUClast was listed and summarized using descriptive statistics.
| h*ng/mL | IV Cipargamin 20 mg | IV Cipargamin 40 mg |
|---|---|---|
| Dose 1 n=18,55 | 8150 (6930 to 9580) | 18800 (16900 to 21000) |
| Dose 2 n=19,55 | 19100 (16100 to 22800) | 38700 (34700 to 43100) |
| Dose 3 n=3,1 | 18600 (6330 to 54400) | 40400 (NA to NA) |
Blood samples were collected for pharmacokinetics characterization. AUC(0-inf) post last dose was listed and summarized using descriptive statistics.
| h*ng/mL | IV Cipargamin 20 mg | IV Cipargamin 40 mg |
|---|---|---|
| Dose 2 n=15,53 | 21300 (18000 to 25200) | 40000 (36000 to 44500) |
| Dose 3 n=3,1 | 18800 (6360 to 55500) | 40400 (NA to NA) |
Blood samples were collected for pharmacokinetics characterization. AUC(0-24h) was listed and summarized using descriptive statistics.
| h*ng/mL | IV Cipargamin 20 mg | IV Cipargamin 40 mg |
|---|---|---|
| Dose 1 n=18,55 | 8170 (6950 to 9590) | 19200 (17300 to 21300) |
| Dose 2 n=19,54 | 11900 (10700 to 13200) | 28500 (25900 to 31400) |
| Dose 3 n=3,1 | 10100 (5800 to 17600) | 26500 (NA to NA) |
Blood samples were collected for pharmacokinetics characterization. The half-life post last dose was summarized using descriptive statistics.
| hours | IV Cipargamin 20 mg | IV Cipargamin 40 mg |
|---|---|---|
| Dose 2 n=15,53 | 18 (15.7 to 20.7) | 11.6 (10.6 to 12.6) |
| Dose 3 n=3,1 | 16.2 (8.35 to 31.4) | 10.8 (NA to NA) |
Blood samples were collected for pharmacokinetics characterization. CL post last dose was summarized using descriptive statistics.
| L/h | IV Cipargamin 20 mg | IV Cipargamin 40 mg |
|---|---|---|
| Dose 2 n=15,53 | 0.939 (0.793 to 1.11) | 0.66 (0.576 to 0.755) |
| Dose 3 n=3,1 | 1.06 (0.36 to 3.15) | 0.99 (NA to NA) |
Blood samples were collected for pharmacokinetics characterization. Vz post last dose was listed and summarized using descriptive statistics.
| liters | IV Cipargamin 20 mg | IV Cipargamin 40 mg |
|---|---|---|
| Dose 2 n=15,53 | 24.5 (21.2 to 28.2) | 11 (9.34 to 13) |
| Dose 3 n=3,1 | 24.9 (15 to 41.1) | 15.5 (NA to NA) |
Collected over Adverse events were reported from first dose of study treatment until end of study treatment plus 29 days post treatment, up to a maximum duration of 36 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV Cipargamin 20 mg | 0/20 (0%) | 0/20 (0%) | 7/20 (35%) |
| IV Cipargamin 40 mg | 0/114 (0%) | 5/114 (4.4%) | 57/114 (50%) |
| IV Artesunate | 0/117 (0%) | 4/117 (3.4%) | 50/117 (42.7%) |
| Total | 0/251 (0%) | 9/251 (3.6%) | 114/251 (45.4%) |
| Event | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate | Total |
|---|---|---|---|---|
| MalariaInfections and infestations | 0/20 | 2/114 | 0/117 | 2/251 |
| AnaemiaBlood and lymphatic system disorders | 0/20 | 1/114 | 2/117 | 3/251 |
| Hepatic function abnormalHepatobiliary disorders | 0/20 | 1/114 | 0/117 | 1/251 |
| SeizureNervous system disorders | 0/20 | 1/114 | 0/117 | 1/251 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/20 | 0/114 | 1/117 | 1/251 |
| Haemoglobin decreasedInvestigations | 0/20 | 0/114 | 1/117 | 1/251 |
| QuadriparesisNervous system disorders | 0/20 | 0/114 | 1/117 | 1/251 |
| Event | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate | Total |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 5/20 | 40/114 | 35/117 | 80/251 |
| MalariaInfections and infestations | 0/20 | 16/114 | 12/117 | 28/251 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/20 | 1/114 | 2/117 | 5/251 |
| RhinitisInfections and infestations | 1/20 | 7/114 | 4/117 | 12/251 |
| Upper respiratory tract infectionInfections and infestations | 0/20 | 7/114 | 5/117 | 12/251 |
The full analysis set included all randomized participants who had baseline P. falciparum count \>0 and took at least one dose of intravenous study treatment during the treatment period.
| Age, Continuous(years) | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate | Total |
|---|---|---|---|---|
| Mean | 22.7 ± 10.07 | 7.7 ± 7.81 | 8.6 ± 9.13 | 9.3 ± 9.47 |
| Age, Customized(Participants) | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate | Total |
|---|---|---|---|---|
| 6 months to < 2 years | 0 | 21 | 18 | 39 |
| 2 to <6 years | 0 | 37 | 39 | 76 |
| 6 to <12 years | 0 | 38 | 40 | 78 |
| 12 to <18 years | 9 | 7 | 7 | 23 |
| 18 to <65 years | 11 | 11 | 13 | 35 |
| Sex: Female, Male(Participants) | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate | Total |
|---|---|---|---|---|
| Female | 9 | 49 | 64 | 122 |
| Male | 11 | 65 | 53 | 129 |
| Race/Ethnicity, Customized(Participants) | IV Cipargamin 20 mg | IV Cipargamin 40 mg | IV Artesunate | Total |
|---|---|---|---|---|
| Black or African American | 20 | 114 | 117 | 251 |
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 participants 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
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: NITD 609