A Phase 2 interventional study of KAE609 and Coartem in Malaria, sponsored by Novartis Pharmaceuticals. Completed at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-11.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
Among 20 studies in Malaria by Novartis Pharmaceuticals — 3 open to participants now, 3 under way, none of them phase 3. Malaria · Novartis Pharmaceuticals.
Among the 20 studies in Malaria by Novartis Pharmaceuticals, this one is the 5th largest by enrollment of the 17 interventional ones, is the only one that started in 2017, is one of 6 in phase 2, and was the 9th registered.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 188 is below the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →3 of the 20 studies in Malaria by Novartis Pharmaceuticals are open now, in 6 countries. Each count lists the studies.
Of the 51 Malaria studies recruiting now, 15 (29%) set no upper age limit and 33 (65%) stop at 75 or younger; 37 take children under 18; 31 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2017.
Median enrollment 43 across the 17 interventional studies, 254 across the 2 observational. Of the 17 that completed or were terminated, 8 (47%) have results posted.
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.
1 of the studies in Malaria by Novartis Pharmaceuticals that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07896746Novartis PharmaceuticalsFactors Influencing Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda | 2027-01-30 |
Among the 20 studies in Malaria by Novartis Pharmaceuticals, from their registry updates:
KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients.
KEY Inclusion Criteria:
KEY Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KAE609 10 mg once daily (QD) for 1 day
Drug: KAE609
KAE609 25 mg once daily (QD) for 1 day
Drug: KAE609
KAE609 10 mg (QD) for 3 days
Drug: KAE609
KAE609 50 mg once daily (QD) for 1 day
Drug: KAE609
KAE609 25 mg once daily (QD) for 3 days
Drug: KAE609
KAE609 75 mg once daily (QD) for 1 day
Drug: KAE609
KAE609 50 mg once daily (QD) for 3 days
Drug: KAE609
KAE609 150 mg once daily (QD) for 1 day
Drug: KAE609
Coartem® control
Drug: Coartem
Exploration of different doses of KAE609 to establish safety profile.
Also known as: Cipargamin
Control Arm
Also known as: Artemether Lumefantrine
Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)
The occurrence of at least 2 CTCAE grades increase from baseline in ALT or AST during the 4 weeks study period was evaluated to characterize hepatic safety aspects of single and multiple ascending doses of KAE609 in adult malaria subjects for treatment of uncomplicated malaria caused by plasmodium falciparum. If 2 patients in a 10 patient cohort (Cohorts 1 and 2) or 3 patients in a 20 patient cohort (Cohorts 3, 4 and 5) had at least 2 CTCAE grades increase from Baseline in ALT or AST, recruitment was suspended and a review of liver safety (and any other relevant data) by safety review committee was initiated. Any further progression of the study was based on the decision by the safety review committee.
Time frame: Day 29
Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29
PCR-corrected and PCR-uncorrected were evaluated at Days 15 and 29 (i.e., 14 and 28 days post-dose). The presence of parasitaemia after 7 days due to reinfection was considered as PCR-corrected ACPR. Missing blood smear data at Day 15 visit and thereafter were not considered as responder for the visit unless there was a later blood smear test indicating no parasitaemia.
Time frame: Day 15, Day 29
Parasite Clearance Time (PCT)
Parasite Clearance Time (PCT) is 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 48 hours. In case a patient received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication.
Time frame: Day 29
Fever Clearance Time (FCT)
Fever Clearance Time (FCT) is 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. In case a patient received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication.
Time frame: Day 29
Time to Recrudescence and Reinfection at Study Day 29
Time to recrudescence is calculated from the date of first study medication to the date of first event. Participants without recrudescence/reinfection after Day 7 are censored at the time of treatment failure or at the time of last parasite assessment if no treatment failure occured.
Time frame: Day 29
Maximum Peak Observed Concentration (Cmax)
Maximum Peak Observed Concentration (Cmax)
Time frame: Day 1, Day 3
Tmax
Tmax
Time frame: Day 1, Day 3
AUC0-24
AUC0-24
Time frame: Day 1, Day 3
Half-life (T^1/2)
Half-life (T\^1/2)
Time frame: Upto day 15 post dose
This study was conducted in 10 centers in 5 countries: Mali (2), Uganda (3), Ghana (2), Gabon (1), Rwanda (2).
| Milestone | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD | Pooled Coartem Control |
|---|---|---|---|---|---|---|---|---|---|
| Started | 10 | 10 | 12 | 20 | 22 | 20 | 21 | 22 | 51 |
| Completed | 9 | 10 | 12 | 20 | 21 | 19 | 21 | 22 | 51 |
| Not completed | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Technical problems | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Subject/guardian decision | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Milestone | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD | Pooled Coartem Control |
|---|---|---|---|---|---|---|---|---|---|
| Started | 9 | 10 | 12 | 20 | 21 | 19 | 21 | 22 | 51 |
| Completed | 9 | 10 | 12 | 20 | 21 | 19 | 20 | 22 | 50 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Withdrew: Subject/guardian decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
The occurrence of at least 2 CTCAE grades increase from baseline in ALT or AST during the 4 weeks study period was evaluated to characterize hepatic safety aspects of single and multiple ascending doses of KAE609 in adult malaria subjects for treatment of uncomplicated malaria caused by plasmodium falciparum. If 2 patients in a 10 patient cohort (Cohorts 1 and 2) or 3 patients in a 20 patient cohort (Cohorts 3, 4 and 5) had at least 2 CTCAE grades increase from Baseline in ALT or AST, recruitment was suspended and a review of liver safety (and any other relevant data) by safety review committee was initiated. Any further progression of the study was based on the decision by the safety review committee.
| Percentage of Participants | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD | Pooled Coartem Control |
|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) | 11.1 (0.3 to 48.2) | 0 (0.0 to 30.8) | 0 (0.0 to 26.5) | 0 (0.0 to 16.8) | 0 (0.0 to 16.1) | 0 (0.0 to 17.6) | 0 (0.0 to 16.1) | 4.5 (0.1 to 22.8) | 3.9 (0.5 to 13.5) |
PCR-corrected and PCR-uncorrected were evaluated at Days 15 and 29 (i.e., 14 and 28 days post-dose). The presence of parasitaemia after 7 days due to reinfection was considered as PCR-corrected ACPR. Missing blood smear data at Day 15 visit and thereafter were not considered as responder for the visit unless there was a later blood smear test indicating no parasitaemia.
| Percentage of Participants | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD | Pooled Coartem Control |
|---|---|---|---|---|---|---|---|---|---|
| Day 15: PCR corrected | 90.0 (55.50 to 99.75) | 90.0 (55.50 to 99.75) | 83.3 (51.59 to 97.91) | 95.0 (75.13 to 99.87) | 95.2 (76.18 to 99.88) | 84.2 (60.42 to 96.62) | 90.5 (69.62 to 98.83) | 77.3 (54.63 to 92.18) | 96.1 (86.54 to 99.52) |
| Day 15: PCR uncorrected | 90.0 (55.50 to 99.75) | 90.0 (55.50 to 99.75) | 83.3 (51.59 to 97.91) | 95.0 (75.13 to 99.87) | 95.2 (76.18 to 99.88) | 84.2 (60.42 to 96.62) | 85.7 (63.66 to 96.95) | 77.3 (54.63 to 92.18) | 96.1 (86.54 to 99.52) |
| Day 29: PCR corrected | 80.0 (44.39 to 97.48) | 90.0 (55.50 to 99.75) | 83.3 (51.59 to 97.91) | 90.0 (68.30 to 98.77) | 85.7 (63.66 to 96.95) | 73.7 (48.80 to 90.85) | 81.0 (58.09 to 94.55) | 68.2 (45.13 to 86.14) | 94.1 (83.76 to 98.77) |
| Day 29: PCR uncorrected | 80.0 (44.39 to 97.48) | 90.0 (55.50 to 99.75) | 66.7 (34.89 to 90.08) | 80.0 (56.34 to 94.27) | 81.0 (58.09 to 94.55) | 68.4 (43.45 to 87.42) | 71.4 (47.82 to 88.72) | 59.1 (36.35 to 79.29) | 92.2 (81.12 to 97.82) |
Parasite Clearance Time (PCT) is 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 48 hours. In case a patient received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication.
| Hours | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD | Pooled Coartem Control |
|---|---|---|---|---|---|---|---|---|---|
| Parasite Clearance Time (PCT) | 26.8 ± 5.44 | 27.7 ± 4.96 | 14.0 ± 2.63 | 11.4 ± 1.82 | 11.1 ± 1.58 | 9.8 ± 0.97 | 8.7 ± 0.97 | 8.0 ± 1.09 | 36.2 ± 3.72 |
Fever Clearance Time (FCT) is 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. In case a patient received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication.
| Hours | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD | Pooled Coartem Control |
|---|---|---|---|---|---|---|---|---|---|
| Fever Clearance Time (FCT) | 3.9 ± NA | 2.0 ± 0.02 | NA ± NA | 22.0 ± 14.03 | 2.4 ± 0.93 | 7.2 ± 1.47 | 5.7 ± 2.02 | 9.9 ± 3.88 | 13.0 ± 4.29 |
Time to recrudescence is calculated from the date of first study medication to the date of first event. Participants without recrudescence/reinfection after Day 7 are censored at the time of treatment failure or at the time of last parasite assessment if no treatment failure occured.
| Event probability | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD | Pooled Coartem Control |
|---|---|---|---|---|---|---|---|---|---|
| Recrudescence | 12.5 (1.86 to 61.30) | 10.0 (1.47 to 52.70) | 16.7 (4.45 to 51.83) | 10.0 (2.60 to 34.40) | 16.0 (5.42 to 41.93) | 26.3 (11.90 to 52.11) | 15.9 (5.40 to 41.67) | 32.5 (16.93 to 56.43) | 2.4 (0.34 to 15.72) |
| Reinfection | — | — | 25.0 (6.91 to 68.52) | 14.3 (3.78 to 46.06) | 5.0 (0.72 to 30.53) | 10.0 (1.47 to 52.70) | 10.3 (2.67 to 35.25) | 13.3 (3.51 to 43.61) | 2.4 (0.34 to 15.72) |
Maximum Peak Observed Concentration (Cmax)
| ng/mL | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD |
|---|---|---|---|---|---|---|---|---|
| Day 1 | 179 ± 38.2 | 185 ± 51.2 | 379 ± 42.1 | 503 ± 44.3 | 773 ± 32.4 | 828 ± 35.4 | 1270 ± 41.3 | 2360 ± 28.5 |
| Day 3 | — | 235 ± 37.0 | — | 655 ± 27.9 | — | 1210 ± 30.7 | — | — |
Tmax
| Hour | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD |
|---|---|---|---|---|---|---|---|---|
| Day 1 | 4.00 (1.02 to 12.10) | 3.92 (1.03 to 6.17) | 4.01 (2.00 to 8.33) | 4.25 (2.00 to 23.80) | 4.12 (1.97 to 10.00) | 4.12 (2.00 to 6.13) | 6.01 (3.97 to 12.30) | 8.07 (1.00 to 24.10) |
| Day 3 | — | 52.7 (50.00 to 60.60) | — | 52.1 (49.90 to 59.60) | — | 52.0 (50.00 to 60.50) | — | — |
AUC0-24
| h*ug/mL | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD |
|---|---|---|---|---|---|---|---|---|
| Day 1 | 2.77 ± 48.9 | 2.59 ± 38.0 | 5.14 ± 52.5 | 8.39 ± 45.1 | 11.6 ± 37.7 | 15.6 ± 27.2 | 21.4 ± 41.5 | 40.4 ± 26.6 |
| Day 3 | — | 3.90 ± 38.5 | — | 10.9 ± 29.7 | — | 21.6 ± 31.3 | — | — |
Half-life (T\^1/2)
| Hour | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD |
|---|---|---|---|---|---|---|---|---|
| Day 1 | 24.4 ± 8.70 | 18.5 ± 6.24 | 35.1 ± 13.9 | 17.4 ± 3.27 | 31.5 ± 17.4 | 32.8 ± 5.05 | 25.3 ± 8.94 | 29.9 ± 12.5 |
| Day 3 | — | 32.4 ± 14.8 | — | 30.1 ± 14.0 | — | 29.9 ± 22.0 | — | — |
Collected over All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KAE609 10mg SD | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| KAE609 10mg QD@3 Days | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| KAE609 25mg SD | 0/12 (0%) | 0/12 (0%) | 10/12 (83.3%) |
| KAE609 25mg QD@3 Days | 0/20 (0%) | 0/20 (0%) | 10/20 (50%) |
| KAE609 50mg SD | 0/21 (0%) | 0/21 (0%) | 9/21 (42.9%) |
| KAE609 50mg QD@3 Days | 0/19 (0%) | 1/19 (5.3%) | 16/19 (84.2%) |
| KAE609 75mg SD | 0/21 (0%) | 2/21 (9.5%) | 15/21 (71.4%) |
| KAE609 150mg SD | 0/22 (0%) | 1/22 (4.5%) | 12/22 (54.5%) |
| Pooled Coartem | 0/51 (0%) | 1/51 (2%) | 25/51 (49%) |
| Event | KAE609 10mg SD | KAE609 10mg QD@3 Days | KAE609 25mg SD | KAE609 25mg QD@3 Days | KAE609 50mg SD | KAE609 50mg QD@3 Days | KAE609 75mg SD | KAE609 150mg SD | Pooled Coartem |
|---|---|---|---|---|---|---|---|---|---|
| Blood bilirubin increasedInvestigations | 0/10 | 0/10 | 0/12 | 0/20 | 0/21 | 1/19 | 0/21 | 0/22 | 1/51 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/10 | 0/10 | 0/12 | 0/20 | 0/21 | 0/19 | 1/21 | 0/22 | 0/51 |
| Blood alkaline phosphatase increasedInvestigations | 0/10 | 0/10 | 0/12 | 0/20 | 0/21 | 0/19 | 1/21 | 0/22 | 0/51 |
| Alanine aminotransferase increasedInvestigations | 0/10 | 0/10 | 0/12 | 0/20 | 0/21 | 0/19 | 0/21 | 1/22 | 0/51 |
| Event | KAE609 10mg SD | KAE609 10mg QD@3 Days | KAE609 25mg SD | KAE609 25mg QD@3 Days | KAE609 50mg SD | KAE609 50mg QD@3 Days | KAE609 75mg SD | KAE609 150mg SD | Pooled Coartem |
|---|---|---|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 3/10 | 5/10 | 1/12 | 1/20 | 2/21 | 2/19 | 5/21 | 0/22 | 9/51 |
| MalariaInfections and infestations | 1/10 | 0/10 | 2/12 | 4/20 | 4/21 | 5/19 | 5/21 | 9/22 | 1/51 |
| Treatment failureGeneral disorders | 0/10 | 1/10 | 3/12 | 1/20 | 0/21 | 1/19 | 0/21 | 0/22 | 2/51 |
| InfluenzaInfections and infestations | 0/10 | 0/10 | 0/12 | 1/20 | 0/21 | 3/19 | 2/21 | 3/22 | 2/51 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/10 | 0/10 | 1/12 | 1/20 | 1/21 | 2/19 | 0/21 | 0/22 | 1/51 |
| LeukopeniaBlood and lymphatic system disorders | 0/10 | 1/10 | 0/12 | 0/20 | 0/21 | 0/19 | 0/21 | 0/22 | 0/51 |
| Abdominal painGastrointestinal disorders | 1/10 | 0/10 | 0/12 | 0/20 | 0/21 | 0/19 | 1/21 | 0/22 | 1/51 |
| DiarrhoeaGastrointestinal disorders | 1/10 | 0/10 | 1/12 | 0/20 | 0/21 | 0/19 | 1/21 | 0/22 | 3/51 |
| DyspepsiaGastrointestinal disorders | 0/10 | 1/10 | 0/12 | 0/20 | 0/21 | 0/19 | 0/21 | 0/22 | 0/51 |
| GastritisGastrointestinal disorders | 1/10 | 0/10 | 0/12 | 0/20 | 0/21 | 0/19 | 0/21 | 0/22 | 0/51 |
Randomized set (RAN)
| Age, Continuous(Years) | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD | Pooled Coartem Control | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 31.5 ± 10.48 | 35.4 ± 13.25 | 33.0 ± 14.96 | 31.9 ± 10.67 | 33.9 ± 12.56 | 26.4 ± 7.18 | 28.2 ± 10.25 | 30.6 ± 12.57 | 26.2 ± 9.07 | 29.7 ± 11.07 |
| Sex: Female, Male(Participants) | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD | Pooled Coartem Control | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Female | 2 | 6 | 8 | 11 | 9 | 8 | 5 | 6 | 18 | 73 |
| Male | 8 | 4 | 4 | 9 | 13 | 12 | 16 | 16 | 33 | 115 |
| Race/Ethnicity, Customized(Participants) | KAE609 10 mg SD | KAE609 10 mg QD 3 Days | KAE609 25 mg SD | KAE609 25 mg QD 3 Days | KAE609 50 mg SD | KAE609 50 mg QD 3 Days | KAE609 75 mg SD | KAE609 150 mg SD | Pooled Coartem Control | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Black or African American | 10 | 10 | 12 | 20 | 22 | 20 | 21 | 22 | 51 | 188 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Studies of the drug tested here: NITD 609