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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003284-25 | EudraCT Number |
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| Name | Class |
|---|---|
| Medicines for Malaria Venture | OTHER |
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This study was designed to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated Plasmodium falciparum malaria.
There is unmet medical need for anti-malarial treatment with new mechanism of action to reduce probability of developing resistance, and for duration shorter than 3 days of treatment and/or reduced pill burden.
This was a Phase 2 multi-center and open-label study with a single cohort pharmacokinetic (PK) Run-in Part followed by 2 randomized parallel-group parts, Part A and Part B, in adults and children with confirmed and uncomplicated Plasmodium falciparum malaria. Each part (PK Run-in, Part A and Part B) had the same design structure: A screening phase of up to 24 hours where participants were evaluated for eligibility and randomized (Part A and B) into different cohorts. A treatment phase of up to 3 days where participants were treated for 1, 2 or 3 consecutive days. Finally, participants were followed up until Day 43, where the rescue medication was the local standard at the discretion of the Investigator and participants
PK Run-in part: Adult/adolescent participants (≥ 12 years old) were dosed with a single dose of 200 mg KAF156 and 960 mg LUM-SDF at Day 1. The purpose of this part was to assess potential PK interactions between the compounds when dosed together.
Part A: Adult/adolescent participants (≥ 12 years old) were randomized into one of seven cohorts in a 2:2:2:2:2:2:1 ratio: six KAF156 and LUM-SDF cohorts at starting doses of 400 mg and 480 mg once daily (QD) for 1 day respectively and a control arm (Coartem twice a day (BID) for 3 days). Upon completion of Part A, all the dosing groups were evaluated in an interim assessment to determine the effective and tolerated KAF156 and LUM-SDF dosing regimen and dosages to be used in Part B.
Part B: Children participants (2 to < 12 years old) were randomized to three KAF156 and LUM-SDF cohorts at dosages and dosing regimens selected from Part A and the control arm (Coartem) in a 2:2:2:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day | Experimental | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
|
| Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day | Experimental | Participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg |
|
| Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days | Experimental | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
|
| Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days | Experimental | Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
|
| Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days | Experimental | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAF156 | Drug | KAF156 comes in 100 mg tablets for oral administration. KAF156 was administered in combination with LUM-SDF once daily (QD) for 1, 2 or 3 days at 200 mg, 400 mg or 800 mg doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at Day 29 (i.e., 28 days post first dose) based on the short half-life of the study drugs. Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR at Day 29 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 29 irrespective of axillary temperature unless the presence of parasitaemia after 7 days was due to reinfection based on PCR. A presence of parasitaemia after 7 days of treatment initiation was considered as a reinfection only if the parasitaemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. | 28 days post first dose |
| PK Run-in: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Treatment Dose (AUC0-24h) of KAF156 | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUC0-24h was determined using non-compartmental methods. | 0, 1, 3, 6, 12, 18 and 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Uncorrected Adequate Clinical and Parasitological Response (ACPR) | PCR-uncorrected ACPR defined as the absence of parasitaemia was evaluated at days 15, 29 and 43 (i.e., 14, 28 and 42 days post first dose). A participant was considered as PCR-uncorrected ACPR at Days 15, 29 or 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Days 15, 29 or 43 irrespective of axillary temperature. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Nanoro | Burkina Faso | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39344281 | Derived | Sangana R, Ogutu B, Yeka A, Kusemererwa S, Tinto H, Toure AO, Kibuuka A, Lingani M, Lourenco C, Mombo-Ngoma G, Nduba V, Landry N'Guessan T, Nassa GJW, Nyantaro M, Tina LO, Anvikar A, Sinha A, Kaguthi G, Fofana B, Grobusch MP, Gaaloul ME, Marrast AC, Pathan R, Chikoto H, Csermak K, Risterucci C, Su G, Winnips C, Zhang J, Zack J. Pharmacokinetics of Ganaplacide and Lumefantrine in Adults, Adolescents, and Children with Plasmodium falciparum Malaria Treated with Ganaplacide Plus Lumefantrine Solid Dispersion Formulation: Analysis of Data from a Multinational Phase 2 Study. J Clin Pharmacol. 2025 Feb;65(2):179-189. doi: 10.1002/jcph.6138. Epub 2024 Sep 29. | |
| 37327809 |
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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 https://www.clinicalstudydatarequest.com/.
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Before being enrolled in the study, participants underwent a prescreening evaluation to ascertain the Plasmodium falciparum parasitemia count.
Participants were recruited from 13 sites in 10 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 200 mg and LUM-SDF 960 mg |
| FG001 | Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 13, 2018 | Dec 21, 2021 |
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| Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days | Experimental | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
|
| Part A - Cohort 7: Coartem | Active Comparator | Participants received Coartem twice daily via oral administration for 3 days |
|
| PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 day | Experimental | Participants received a single oral dose of KAF156 200 mg and LUM-SDF 960 mg |
|
| Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day | Experimental | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
|
| Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days | Experimental | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
|
| Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days | Experimental | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
|
| Part B - Cohort 4: Coartem | Active Comparator | Participants received Coartem twice daily via oral administration for 3 days |
|
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| Coartem | Drug | Coartem comes as 20/120 mg dispersible tablets or 80/480 mg tablets for oral administration. Coartem was administered twice daily for 3 days as active comparator. |
|
| Lumefantrine Solid Dispersion Formulation | Drug | LUM-SDF comes in 240 mg or 480 mg sachets for oral administration. LUM-SDF was administered in combination with KAF156 once daily (QD) for 1, 2 or 3 days at 480 mg or 960 mg doses. |
|
|
| 14, 28 and 42 days post first dose |
| Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) | PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at days 15 and 43 (i.e., 14 and 42 days post first dose). Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR at Day 15 or Day 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 15 or Day 43 irrespective of axillary temperature unless the presence of parasitaemia after 7 days was due to reinfection based on PCR. A presence of parasitaemia after 7 days of treatment initiation was considered as a reinfection only if the parasitaemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. | 14 and 42 days post first dose |
| Part A and Part B: Number of Participants With Recrudescence Events | Recrudescence is defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Recrudescence must be confirmed by PCR analysis. | 42 days post first dose |
| Part A and Part B: Number of Participants With Reinfection Events | Reinfection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. Reinfection must be confirmed by PCR analysis. | 42 days post first dose |
| Part A and Part B: 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 participant received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication. | 42 days post first dose |
| PK Run-in, Part A and Part B: 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 participant received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication. | 42 days post first dose |
| PK Run-in, Part A and Part B: Number of Participants With Parasitaemia | Parasitaemia is the quantitative content of parasites in the blood determined by microscopy examination validated methods. Only Plasmodium Falciparum asexual form is used for parasitaemia assessments. | 12, 24 and 48 hours post last dose |
| Part A and Part B: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Last Treatment Dose (AUC0-24h) of KAF156 | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUC0-24h was determined using non-compartmental methods. | 3, 6, 18 and 24 hours post last dose |
| Part A and Part B: Maximum Peak Observed Concentration (Cmax) of KAF156 | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Cmax was determined using non-compartmental methods. | 3, 6, 18, 24, 27, 30, 48, 51, 54, 68, 72 and 168 hours post last dose |
| PK Run-in and Part A: Elimination Half-life (T½) of KAF156 | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. T½ was determined using non-compartmental methods. | 0, 1, 3, 6, 12, 18, 24, 27, 30, 36, 48, 72, 96 and 168 hours post last dose |
| PK Run-in and Part A (Cohorts 1 and 2): Time to Reach Maximum Blood Concentrations (Tmax) of KAF156 | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Tmax was determined using non-compartmental methods. | 0, 1, 3, 6, 12, 18, 24, 30, 48, 96 and 168 hours post last dose |
| Lambaréné |
| Gabon |
| Novartis Investigative Site | Ranchi | Jharkhand | 834009 | India |
| Novartis Investigative Site | Kombewa | Kenya |
| Novartis Investigative Site | Siaya | 2300 | Kenya |
| Novartis Investigative Site | Sotouba | Mali |
| Novartis Investigative Site | Chokwé | Mozambique |
| Novartis Investigative Site | Tak | 63140 | Thailand |
| Novartis Investigative Site | Masaka | Uganda |
| Novartis Investigative Site | Tororo | Uganda |
| Novartis Investigative Site | Binh Phuoc Province | VNM | 830000 | Vietnam |
| Derived |
| Ogutu B, Yeka A, Kusemererwa S, Thompson R, Tinto H, Toure AO, Uthaisin C, Verma A, Kibuuka A, Lingani M, Lourenco C, Mombo-Ngoma G, Nduba V, N'Guessan TL, Nassa GJW, Nyantaro M, Tina LO, Singh PK, El Gaaloul M, Marrast AC, Chikoto H, Csermak K, Demin I, Mehta D, Pathan R, Risterucci C, Su G, Winnips C, Kaguthi G, Fofana B, Grobusch MP. Ganaplacide (KAF156) plus lumefantrine solid dispersion formulation combination for uncomplicated Plasmodium falciparum malaria: an open-label, multicentre, parallel-group, randomised, controlled, phase 2 trial. Lancet Infect Dis. 2023 Sep;23(9):1051-1061. doi: 10.1016/S1473-3099(23)00209-8. Epub 2023 Jun 13. |
Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
| FG002 | Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg |
| FG003 | Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| FG004 | Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| FG005 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| FG006 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| FG007 | Part A - Cohort 7: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
| FG008 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| FG009 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| FG010 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| FG011 | Part B - Cohort 4: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
|
| Full Analysis Set (FAS) | All enrolled participants, who received at least one dose of the study treatment |
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| Pharmacokinetics (PK) Analysis Set | All enrolled participants with at least 80% compliance to study treatment who had evaluable PK parameter data and did not receive the prohibited medications which could impact PK parameters. |
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| Per-Protocol Set (PPS) | All participants comprised in FAS who met predefined criteria related to protocol and treatment compliance. |
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| Rich Pharmacokinetics (PK) Analysis Subset | Subset of participants within PK Run-in and Part A and comprised in PK Analysis set from whom rich PK data was collected. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 200 mg and LUM-SDF 960 mg |
| BG001 | Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| BG002 | Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg |
| BG003 | Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| BG004 | Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| BG005 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| BG006 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| BG007 | Part A - Cohort 7: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
| BG008 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| BG009 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| BG010 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| BG011 | Part B - Cohort 4: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
| BG012 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
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| Primary | Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 29 | PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at Day 29 (i.e., 28 days post first dose) based on the short half-life of the study drugs. Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR at Day 29 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 29 irrespective of axillary temperature unless the presence of parasitaemia after 7 days was due to reinfection based on PCR. A presence of parasitaemia after 7 days of treatment initiation was considered as a reinfection only if the parasitaemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. | All participants comprised in Per-protocol Set (PPS) | Posted | Count of Participants | Participants | 28 days post first dose |
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| Primary | PK Run-in: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Treatment Dose (AUC0-24h) of KAF156 | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUC0-24h was determined using non-compartmental methods. | Pharmacokinetics (PK) Analysis Set. Only participants with available PK data at the specified time point were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*μg/mL | 0, 1, 3, 6, 12, 18 and 24 hours post-dose |
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| Secondary | Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Uncorrected Adequate Clinical and Parasitological Response (ACPR) | PCR-uncorrected ACPR defined as the absence of parasitaemia was evaluated at days 15, 29 and 43 (i.e., 14, 28 and 42 days post first dose). A participant was considered as PCR-uncorrected ACPR at Days 15, 29 or 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Days 15, 29 or 43 irrespective of axillary temperature. | All participants comprised in Full Analysis Set (FAS) | Posted | Count of Participants | Participants | 14, 28 and 42 days post first dose |
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| Secondary | Part A and Part B: Number of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) | PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at days 15 and 43 (i.e., 14 and 42 days post first dose). Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR at Day 15 or Day 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 15 or Day 43 irrespective of axillary temperature unless the presence of parasitaemia after 7 days was due to reinfection based on PCR. A presence of parasitaemia after 7 days of treatment initiation was considered as a reinfection only if the parasitaemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. | All participants comprised in Per-protocol Set (PPS) | Posted | Count of Participants | Participants | 14 and 42 days post first dose |
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| Secondary | Part A and Part B: Number of Participants With Recrudescence Events | Recrudescence is defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Recrudescence must be confirmed by PCR analysis. | All participants comprised in Full Analysis Set (FAS). | Posted | Count of Participants | Participants | 42 days post first dose |
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| Secondary | Part A and Part B: Number of Participants With Reinfection Events | Reinfection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. Reinfection must be confirmed by PCR analysis. | All participants comprised in Full Analysis Set (FAS). | Posted | Count of Participants | Participants | 42 days post first dose |
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| Secondary | Part A and Part B: 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 participant received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication. | Full Analysis Set (FAS). Only participants with fever at baseline and post-baseline assessment of fever clearance at the time point were included in the analysis. | Posted | Mean | Standard Error | Hours | 42 days post first dose |
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| Secondary | PK Run-in, Part A and Part B: 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 participant received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication. | All participants comprised in Full Analysis Set (FAS). | Posted | Mean | Standard Error | Hours | 42 days post first dose |
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| Secondary | PK Run-in, Part A and Part B: Number of Participants With Parasitaemia | Parasitaemia is the quantitative content of parasites in the blood determined by microscopy examination validated methods. Only Plasmodium Falciparum asexual form is used for parasitaemia assessments. | Full Analysis Set (FAS). Only participants with assessment of parasitaemia at the timepoint were included in the analysis. | Posted | Count of Participants | Participants | 12, 24 and 48 hours post last dose |
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| Secondary | Part A and Part B: Area Under the Blood Concentration-time Curve Over the Last 24 Hours After Last Treatment Dose (AUC0-24h) of KAF156 | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUC0-24h was determined using non-compartmental methods. | Pharmacokinetics (PK) Analysis Set. Only participants with available PK data at the specified time point were included in the analysis. As per study design, AUC0-24h was not determined for Part B cohorts 2 and 3. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*μg/mL | 3, 6, 18 and 24 hours post last dose |
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| Secondary | Part A and Part B: Maximum Peak Observed Concentration (Cmax) of KAF156 | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Cmax was determined using non-compartmental methods. | Pharmacokinetics (PK) Analysis Set. Only participants with available PK data at the specified time point were included in the analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 3, 6, 18, 24, 27, 30, 48, 51, 54, 68, 72 and 168 hours post last dose |
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| Secondary | PK Run-in and Part A: Elimination Half-life (T½) of KAF156 | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. T½ was determined using non-compartmental methods. | Rich Pharmacokinetics (PK) Analysis subset. Only participants with available PK data at the specified time point were included in the analysis. | Posted | Mean | Standard Deviation | Hours | 0, 1, 3, 6, 12, 18, 24, 27, 30, 36, 48, 72, 96 and 168 hours post last dose |
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| Secondary | PK Run-in and Part A (Cohorts 1 and 2): Time to Reach Maximum Blood Concentrations (Tmax) of KAF156 | Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Tmax was determined using non-compartmental methods. | Rich Pharmacokinetics (PK) Analysis subset. Only participants with available PK data at the specified time point were included in the analysis. As per study design, Tmax was only determined per PK Run-in and Part A cohorts 1 and 2. | Posted | Mean | Standard Deviation | Hours | 0, 1, 3, 6, 12, 18, 24, 30, 48, 96 and 168 hours post last dose |
|
Adverse events were reported from Day 1 to Day 43, where Day 43 could be 42, 41 or 40 days after end of treatment depending on whether the participant received treatment during 1, 2 or 3 consecutive days respectively.
Any sign or symptom that occurs during the study treatment plus the 40, 41 or 42 days post treatment depending on whether the participant received treatment during 1, 2 or 3 consecutive days respectively.
Part A and Part B safety data was pooled for safety analysis since Part B cohorts 1, 2 and 3 dosages and dosing regimens match with Part A cohorts 1, 3 and 6 respectively. Part B dosages and dosing regimens were selected based on the outcome of the interim assessment in Part A.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PK Run-in: KAF 200 mg and LUM 960 mg QD for 1 Day | PK Run-in participants received a single oral dose of KAF156 200 mg and LUM-SDF 960 mg | 0 | 12 | 0 | 12 | 7 | 12 |
| EG001 | Part A: KAF 800 mg and LUM 960 mg QD for 1 Day | Part A - Cohort 2 participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg | 0 | 51 | 1 | 51 | 37 | 51 |
| EG002 | Part A: KAF 200 mg and LUM 480 mg QD for 3 Days | Part A - Cohort 4 participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days | 0 | 54 | 2 | 54 | 30 | 54 |
| EG003 | Part A: KAF 400 mg and LUM 480 mg QD for 3 Days | Part A - Cohort 5 participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days | 0 | 51 | 1 | 51 | 32 | 51 |
| EG004 | Part A and Part B: KAF 400 mg and LUM 960 mg QD for 1 Day | Part A - Cohort 1 and Part B - Cohort 1 participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg | 0 | 103 | 7 | 103 | 69 | 103 |
| EG005 | Part A and Part B: KAF 400 mg and LUM 960 mg QD for 2 Days | Part A - Cohort 3 and Part B - Cohort 2 participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days | 0 | 104 | 5 | 104 | 68 | 104 |
| EG006 | Part A and Part B: KAF 400 mg and LUM 960 mg QD for 3 Days | Part A - Cohort 6 and Part B - Cohort 3 participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days | 0 | 97 | 2 | 97 | 59 | 97 |
| EG007 | Part A and Part B: Coartem | Part A - Cohort 7 and Part B - Cohort 4 participants received Coartem twice daily via oral administration for 3 days | 0 | 51 | 3 | 51 | 30 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Plasmodium falciparum infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Aspartate aminotransferase | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Treatment failure | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Infection parasitic | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2021 | Dec 21, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000599914 | ganaplacide |
| D000077611 | Artemether, Lumefantrine Drug Combination |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG008 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG009 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG010 | Part B - Cohort 4: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
|
| OG003 | Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG004 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG005 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG006 | Part A - Cohort 7: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
| OG007 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| OG008 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG009 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG010 | Part B - Cohort 4: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
|
|
| OG002 | Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG003 | Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG004 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG005 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG006 | Part A - Cohort 7: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
| OG007 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| OG008 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG009 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG010 | Part B - Cohort 4: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
|
|
Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
| OG004 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG005 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG006 | Part A - Cohort 7: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
| OG007 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| OG008 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG009 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG010 | Part B - Cohort 4: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
|
|
Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
| OG004 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG005 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG006 | Part A - Cohort 7: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
| OG007 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| OG008 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG009 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG010 | Part B - Cohort 4: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
|
|
| OG003 |
| Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days |
Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG004 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG005 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG006 | Part A - Cohort 7: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
| OG007 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| OG008 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG009 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG010 | Part B - Cohort 4: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
|
|
Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG004 | Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG005 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG006 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG007 | Part A - Cohort 7: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
| OG008 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| OG009 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG010 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG011 | Part B - Cohort 4: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
|
|
Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG004 | Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG005 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG006 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG007 | Part A - Cohort 7: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
| OG008 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| OG009 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG010 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG011 | Part B - Cohort 4: Coartem | Participants received Coartem twice daily via oral administration for 3 days |
|
|
| OG003 | Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG004 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG005 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG006 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| OG007 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG008 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
|
|
| Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days |
Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG004 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG005 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
| OG006 | Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 Day | Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg |
| OG007 | Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG008 | Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
|
|
Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days |
| OG004 | Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG005 | Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days |
| OG006 | Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 Days | Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|