| Primary | 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. | 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. | Posted | | Number | | percentage of participants | | 12 Hours | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00080.0
- OG00193.0
- OG00239.3
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| Secondary | Percentage of Participants Achieving Clinical Success at 48 Hours | Clinical success was a composite endpoint based on following criteria:
- Was participant dead or alive
- Presence of asexual parasites (yes/no)
- Presence of any of the key signs of severe malaria (yes/no)
| 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. | Posted | | Number | 90% Confidence Interval | percentage of participants | | 48 Hours | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
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| Secondary | 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:
- Altered consciousness - Prostration or GCS < 11 for participants > 5 years / BCS < 3 for participants =< 5 years of age
- Renal Impairment - Serum creatinine > 3xULN or > 3 mg/dL or need for renal replacement therapy
- Acidosis - Serum lactate > 4 mmol/L
- Respiratory distress - present or absent
- Severe anemia - Hb < 5 g/dl or Hb < 7g/dl in pediatric and adults respectively or need of blood transfusion
- Jaundice - Serum bilirubin > 3 g/dl
- Hypoglycemia- plasma glucose < 40 mg/dL
| 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. | Posted | | Number | | percentage of participants | | Baseline to Day 29 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). |
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| Secondary | 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. | The safety set included all participants who took at least one dose of study drug during the treatment period. Number analyzed is the number of participants with available data. | Posted | | Number | | percentage of participants | | Day 8 and Day 29 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). |
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| Secondary | 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. | 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. Number analyzed is the number of participants with available data. | Posted | | Number | | percentage of participants | | Day 29 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
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| Secondary | 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. | 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. | Posted | | Number | | percentage of participants | | 24 hours and 48 hours | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
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| Secondary | 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. | 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. Number analyzed is the number of participants with data available at the specified time point. | Posted | | Median | 95% Confidence Interval | hours | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
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| Secondary | 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. | 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. Number analyzed is the number of participants with data available at the specified time point. | Posted | | Median | Full Range | hours | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
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| Secondary | 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. | 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. Number analyzed is the number of participants with data available at the specified time point. | Posted | | Median | 95% Confidence Interval | hours | | Up to 72 hours | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
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| Secondary | 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. | 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. Number analyzed is the number of participants with data available at the specified time points. | Posted | | Median | Full Range | ratio | | 12 hours, 24 hours, and 48 hours | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
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| Secondary | 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. | 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. Number analyzed is the number of participants with data available at the specified time point. | Posted | | Number | | percentage of participants | | Day 29 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate |
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| Secondary | Time to Switch to Oral Therapy | Time to switch participants from IV therapy to Coartem (standard of drug for oral therapy) was analyzed. | 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. Number analyzed is the number of participants with data available at the specified time point. | Posted | | Median | 95% Confidence Interval | hours | | Day 3 to Day 29 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
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| Secondary | Time to Discharge From Hospital | | 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. Number analyzed is the number of participants with data available at the specified time point. | Posted | | Median | 95% Confidence Interval | hours | | Day 3 to Day 29 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
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| Secondary | Time to Recover From Prostration | To assess recovery of participants as measured by time to recovery from prostration compared to baseline. | 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. Number analyzed is the number of participants with data available at the specified time point. | Posted | | Median | 95% Confidence Interval | hours | | Day 1 to Day 29 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
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| Secondary | 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. | The safety set included all participants who took at least one dose of study drug during the treatment period. | Posted | | Number | | participants | | Day 1 to Day 29 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). | | OG002 | IV Artesunate | Participants received IV artesunate according to label and followed by oral medication (Coartem® b.i.d. for 3 days). |
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| Secondary | 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. | The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data. | Posted | | Geometric Mean | 90% Confidence Interval | ng/mL | | Day 1 - Day 8 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). |
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| Secondary | 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. | The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data. | Posted | | Geometric Mean | 90% Confidence Interval | hours | | Day 1 - Day 8 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). |
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| Secondary | 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. | The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data. | Posted | | Geometric Mean | 90% Confidence Interval | h*ng/mL | | Day 1 - Day 8 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). |
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| Secondary | 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. | The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data. | Posted | | Geometric Mean | 90% Confidence Interval | h*ng/mL | | Day 1 - Day 8 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). |
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| Secondary | 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. | The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data. | Posted | | Geometric Mean | 90% Confidence Interval | h*ng/mL | | Day 1 - Day 8 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). |
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| Secondary | 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. | The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data. | Posted | | Geometric Mean | 90% Confidence Interval | hours | | Day 1 - Day 8 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). |
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| Secondary | 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. | The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data. | Posted | | Geometric Mean | 90% Confidence Interval | L/h | | Day 1 - Day 8 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). |
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| Secondary | 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. | The pharmacokinetics (PK) analysis set included all participants who had at least one valid (i.e. not flagged for exclusion) PK concentration measurement, received at least one dose of study drug, and did not have any protocol deviations that had an impact on PK data. Number analyzed is the number of participants with available data. | Posted | | Geometric Mean | 90% Confidence Interval | liters | | Day 1 - Day 8 | | | | ID | Title | Description |
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| OG000 | IV Cipargamin 20 mg | 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). | | OG001 | IV Cipargamin 40 mg | 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). |
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