A Phase 2 interventional study of KAF156 and LUM-SDF in Uncomplicated Plasmodium Falciparum Malaria, sponsored by Novartis Pharmaceuticals. Completed at 9 sites in 5 countries. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
This study aimed to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to \< 18 years of age) with uncomplicated P. falciparum malaria. There is an unmet medical need for anti-malarial treatment with a new mechanism of action to reduce the probability of developing resistance.
This Phase 2 study aimed to evaluate the efficacy, safety and tolerability of the investigational drug KAF156 and a Solid Dispersion Formulation of lumefantrine (LUM-SDF) when administered in combination in pediatric patients 6 months to \< 18 years of age with uncomplicated Plasmodium falciparum malaria. In addition, pharmacokinetics (PK) of the drug combination was also evaluated.
There were three age-descending cohorts in the study: Run-in Cohort (12 years to \< 18 years), Cohort 1 (2 years to \< 12 years) and Cohort 2 (6 months to \< 2 years). The rationale for separated cohorts 1 and 2 was to allow enrolment of the youngest patients (cohort 2) after safety and exposure review of older patients in cohort 1. Given the age-independent symptoms of acute malaria, and to increase statistical power, for all outcomes measures the cohorts 1 and 2 were pooled (cohort 1/2). This new study first explored the effect of food on lumefantrine and KAF156 pharmacokinetics (PK) in patients 12 to \< 18 years old with malaria caused by P. falciparum. Based on the data from the Run-in Cohort, recommendation on dose, dosing regimen, dosage administration (with food) and duration were provided before younger patients in Cohorts 1 and 2 were dosed with KAF156/LUM-SDF. Then, efficacy, safety, tolerability and PK of the combination of KAF156/LUM-SDF in comparison with Coartem®(Artemether/Lumefantrine) were evaluated in younger patients, in pooled Cohort 1/2.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 295 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In run-in cohort: Male and female patients 12 to \< 18 years of age, with a body weight
Exclusion Criteria:
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs (e.g., HIV patients on ART therapy or TB patients on treatment), or which may jeopardize the patient in case of participation in the study. The investigator should make this determination in consideration of the patient's medical history and/or clinical or laboratory evidence of any of the following:
History of to any of the study drugs or its or to drugs of similar chemical classes
For the Run-in Cohort only:
Women of , defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of during dosing of investigational drug. Basic contraception methods include:
Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug. Women are considered not of child bearing potential if they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
For Cohorts 1 and 2 only:
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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).
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KAF156 and LUM-SDF QD (once daily) for 2 days in fasted condition
Drug: KAF156 · Drug: LUM-SDF
KAF156 and LUM-SDF QD (once daily) for 2 days in fed condition
Drug: KAF156 · Drug: LUM-SDF
KAF156 and LUM-SDF QD (once daily) in 3-day dose regimen. It was administered with a light meal and the full dose was adjusted based on patient´s body weight.
Drug: KAF156 · Drug: LUM-SDF
Coartem® BID twice a day for 3 days (It was administered with a light meal and doses were based on patient's body weight as per product label).
Drug: Coartem
Provided as 100 mg tablets, to be taken QD 2 or 3 Days in combination with LUM-SDF, dose is based on body weight
Provided as 120 mg or 240 mg powder in sachet, to be taken QD 2 or 3 Days in combination with KAF156, dose is based on body weight
Also known as: Lumefantrine Solid Dispersion Formulation
Coartem® (Artemether/Lumefantrine dispersible tablets 20/120mg in blister pack) (for Cohorts 1 and 2), dose is based on body weight
Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) - Cohorts 1 and 2 Pooled
PCR-corrected ACPR, defined as the absence of parasitemia(PS), was evaluated on Day29. 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 Day29 if the participant did not meet any of the criteria of early treatment failure (up to Day4), late clinical failure(Day5 to Day29) or late parasitological failure(Day8 to Day29), and had absence of PS on Day29 irrespective of axillary temperature unless the presence of PS after 7days(Day8 or later) was due to reinfection based on PCR genotyping.A presence of PS after 7days of treatment initiation was considered as a reinfection only if the PS was clear before Day8 and none of the parasite strain(s) detected on Day8 or later match with the parasite strain at baseline based on PCR genotyping.Given the age-independent symptoms of acute malaria, and to increase statistical power,the cohorts 1 and 2 were pooled.
Time frame: Day 29
PCR-corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR)
PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated. Microscopic species identification was confirmed and determined by polymerase chain reaction (PCR) genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 15, 29 or 43 irrespective of axillary temperature unless the presence of parasitemia after 7 days was due to reinfection based on PCR. A presence of parasitemia after 7 days of treatment initiation was considered as a reinfection only if the parasitemia 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. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
Time frame: Corrected ACPR: Day 15, Day 43; Uncorrected ACPR: Day 15, Day 29 and Day 43
PCR-corrected Adequate Clinical and Parasitological Response (ACPR) - Run-in Cohort
PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated on Day 29. Microscopic species identification was confirmed and determined by polymerase chain reaction (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 (ETF) (up to Day 4), late clinical failure (LCF) (Day 5 to Day 29) or late parasitological failure (LPF) (Day 8 to Day 29), and had absence of parasitaemia on Day 29 irrespective of axillary temperature unless the presence of parasitaemia after 7 days (Day 8 or later) was due to reinfection based on PCR genotyping. 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 match with the parasite strain at baseline based on PCR genotyping.
Time frame: Day 29
Parasite Clearance Time (PCT)
PCT is defined as time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. PCT is based on uncorrected parasite counts. PCT was calculated using the Kaplan-Meier method. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
Time frame: up to 43 days
Fever Clearance Times (FCT)
FCT is defined as 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. FCT was calculated using the Kaplan-Meier method. Participants who received any antimalarial medication (including rescue medication) before fever clearance are censored at the first use of antimalarial medication. Participants without fever clearance are censored at the time of last fever assessment. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
Time frame: up to 43 days
Percentage Early Treatment Failure (ETF)
Participants were defined as early treatment failures (ETFs) if they developed danger signs or severe malaria on Day 2, Day 3, or Day 4 in the presence of parasitemia, parasitemia on Day 3 with a count higher than the Day 1 count irrespective of axillary temperature, parasitemia on Day 4 with axillary temperature ≥ 37.5°C, or parasitemia on Day 4 with a count equal to or more than 25% of the count on Day 1. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
Time frame: From Day 1 to Day 4
Percentage Late Clinical Failure (LCF)
Participants were defined as late clinical failures (LCFs) if they developed danger signs or severe malaria on any day from Day 5 to Day 43 in the presence of parasitemia without previously meeting any of the criteria of ETF, or if they had parasitemia and an axillary temperature of ≥ 37.5°C on any day from Day 5 to Day 43 without previously meeting any of the criteria of ETF. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
Time frame: Day 5 to Day 43
Percentage Late Parasitological Failure (LPF)
Participants were defined as late parasitological failures (LPFs) if they had parasitemia on any day from Day 8 to Day 43 and an axillary temperature \< 37.5°C without previously meeting any of the criteria of ETF or LCF. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
Time frame: Day 8 to Day 43
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 had to be confirmed by PCR analysis. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
Time frame: Day 15, Day 29 and Day 43
Number of Participants With New Infections Events
New infection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. New infection had to be confirmed by PCR analysis. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
Time frame: Day 15, Day 29 and Day 43
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment up to a maximum duration of approximately 43 days.
KAF156 and Lumefantrine (LUM) Cmax
Cmax is the maximum observed plasma concentration following drug administration. PK parameters are calculated from plasma concentration-time data using non-compartmental methods. Analyte KAF156 is not applicable for Artemether80mg/LUM480mg arm.
Time frame: Run-in Cohort:Pre-dose,1,3,4,5,6,8,24,25,27,28,29,30,32,48,72,168 hours; Cohort 1 and 2 KAF400mg/LUM480mg-QDx3 6-12 years: 3,6,24,48,51,54,72,168 hours; 6 months -<6 years:24,48,51,54,72,168 hours;Cohort 1 and 2 Artemether80mg/LUM480mg:24,48,68,168 hours
KAF156 and Lumefantrine Area Under Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast)
AUC is the area under the plasma concentration-time curve. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The Artemether80mg/LUM480mg arms (standard of care) involved limited pharmacokinetic sampling at 24, 48, 68, and 168 hours following the first dose administration. In contrast, the KAF156 arms had a more extensive sampling, varying by age group, which included time points at 3, 6, 24, 48, 51, 54, 72, and 168 hours following first dose. Due to the limited sampling in the Artemether80mg/LUM480mg arms, it was not planned (per protocol) to calculate AUC values.
Time frame: Run-in Cohort:Pre-dose,1,3,4,5,6,8,24,25,27,28,29,30,32,48,72,168 hours; Cohort 1 and 2 KAF400mg/LUM480mg-QDx3 6-12 years: 3,6,24,48,51,54,72,168 hours; 6 months -< 6 years: 24,48,51,54,72,168 hours.
KAF156 and Lumefantrine Time to Reach the Maximum Plasma Concentration After Drug Administration (Tmax)
Tmax is the time to reach maximum plasma concentration following drug administration. PK parameters are calculated from plasma concentration-time data using non-compartmental methods. The Artemether80mg/LUM480mg arms (standard of care) involved limited pharmacokinetic sampling at 24, 48, 68, and 168 hours following the first dose administration. In contrast, the KAF156 arm had a more extensive sampling, varying by age group, which included time points at 3, 6, 24, 48, 51, 54, 72, and 168 hours following first dose. PK samples for the Artemether80mg/LUM480mg arms were collected around the expected Tmax (at 68 hours, i.e., 8 hours after the last dose, based on the known Tmax of lumefantrine in Coartem) to determine Cmax values; in line with the protocol, separate Tmax values were not calculated.
Time frame: Run-in Cohort:Pre-dose,1,3,4,5,6,8,24,25,27,28,29,30,32,48,72,168 hours; Cohort 1 and 2 KAF400mg/LUM480mg-QDx3 6-12 years: 3,6,24,48,51,54,72,168 hours; 6 months -< 6 years: 24,48,51,54,72,168 hours.
KAF156 and Lumefantrine Plasma Drug Concentration 168 Hours Post First Dose Administration (C168h)
C168h is the plasma concentration at 168h post first dose administration. PK parameters are calculated from plasma concentration-time data using non-compartmental methods. Analyte KAF156 is not applicable for Artemether80mg/LUM480mg arm.
Time frame: at 168 hours
Participants took part in 10 investigative sites in 5 countries.
| Milestone | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1-KAF400mg/LUM480mg-QDx3 | Cohort 2-KAF400mg/LUM480mg-QDx3 | Cohort 1-Artemether80mg/LUM480mg | Cohort 2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|---|---|
| Started | 25 | 26 | 11 | 13 | 70 | 40 | 70 | 40 |
| Completed | 23 | 26 | 11 | 13 | 67 | 37 | 68 | 34 |
| Not completed | 2 | 0 | 0 | 0 | 3 | 3 | 2 | 6 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 | 2 | 2 | 1 | 3 |
| Withdrew: Guardian decision | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 3 |
PCR-corrected ACPR, defined as the absence of parasitemia(PS), was evaluated on Day29. 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 Day29 if the participant did not meet any of the criteria of early treatment failure (up to Day4), late clinical failure(Day5 to Day29) or late parasitological failure(Day8 to Day29), and had absence of PS on Day29 irrespective of axillary temperature unless the presence of PS after 7days(Day8 or later) was due to reinfection based on PCR genotyping.A presence of PS after 7days of treatment initiation was considered as a reinfection only if the PS was clear before Day8 and none of the parasite strain(s) detected on Day8 or later match with the parasite strain at baseline based on PCR genotyping.Given the age-independent symptoms of acute malaria, and to increase statistical power,the cohorts 1 and 2 were pooled.
| Percentage of participants | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|
| Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) - Cohorts 1 and 2 Pooled | 99.0 (94.4 to 100.0) | 99.0 (94.5 to 100.0) |
PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated. Microscopic species identification was confirmed and determined by polymerase chain reaction (PCR) genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and had absence of parasitemia on Days 15, 29 or 43 irrespective of axillary temperature unless the presence of parasitemia after 7 days was due to reinfection based on PCR. A presence of parasitemia after 7 days of treatment initiation was considered as a reinfection only if the parasitemia 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. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
| Percentage of participants | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|
| Day 15-corrected ACPR | 100.0 (71.5 to 100.0) | 100.0 (84.6 to 100.0) | 100.0 (63.1 to 100.0) | 100.0 (75.3 to 100.0) | 100.0 (96.3 to 100.0) | 100.0 (96.3 to 100.0) |
| Day 43-corrected ACPR | 100.0 (71.5 to 100.0) | 100.0 (84.6 to 100.0) | 87.5 (47.3 to 99.7) | 92.3 (64.0 to 99.8) | 94.9 (88.5 to 98.3) | 96.0 (90.0 to 98.9) |
| Day 15-uncorrected ACPR | 100.0 (71.5 to 100.0) | 100.0 (84.6 to 100.0) | 100.0 (63.1 to 100.0) | 100.0 (75.3 to 100.0) | 100.0 (96.3 to 100.0) | 100.0 (96.3 to 100.0) |
| Day 29-uncorrected ACPR | 90.9 (58.7 to 99.8) | 95.5 (77.2 to 99.9) | 87.5 (47.3 to 99.7) | 100.0 (75.3 to 100.0) | 96.9 (91.3 to 99.4) | 94.9 (88.6 to 98.3) |
| Day 43-uncorrected ACPR | 81.8 (48.2 to 97.7) | 86.4 (65.1 to 97.1) | 62.5 (24.5 to 91.5) | 76.9 (46.2 to 95.0) | 85.7 (77.2 to 92.0) | 85.9 (77.4 to 92.0) |
PCR-corrected ACPR, defined as the absence of parasitemia, was evaluated on Day 29. Microscopic species identification was confirmed and determined by polymerase chain reaction (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 (ETF) (up to Day 4), late clinical failure (LCF) (Day 5 to Day 29) or late parasitological failure (LPF) (Day 8 to Day 29), and had absence of parasitaemia on Day 29 irrespective of axillary temperature unless the presence of parasitaemia after 7 days (Day 8 or later) was due to reinfection based on PCR genotyping. 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 match with the parasite strain at baseline based on PCR genotyping.
| Percentage of participants | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted |
|---|---|---|---|---|
| PCR-corrected Adequate Clinical and Parasitological Response (ACPR) - Run-in Cohort | 100.0 (71.5 to 100.0) | 100.0 (84.6 to 100.0) | 100.0 (63.1 to 100.0) | 100.0 (75.3 to 100.0) |
PCT is defined as time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. PCT is based on uncorrected parasite counts. PCT was calculated using the Kaplan-Meier method. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
| hours | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|
| Parasite Clearance Time (PCT) | 48.1 (36.1 to 48.2) | 36.2 (36.0 to 71.9) | 48.0 (36.0 to 48.2) | 48.0 (24.0 to 48.2) | 47.5 (36.2 to 47.8) | 35.9 (35.6 to 36.0) |
FCT is defined as 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. FCT was calculated using the Kaplan-Meier method. Participants who received any antimalarial medication (including rescue medication) before fever clearance are censored at the first use of antimalarial medication. Participants without fever clearance are censored at the time of last fever assessment. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
| hours | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|
| Fever Clearance Times (FCT) | 23.5 (23.3 to NA) | 23.9 (23.6 to NA) | 23.8 (23.7 to NA) | 27.1 (23.9 to NA) | 23.9 (23.4 to 24.3) | 23.7 (23.5 to 23.9) |
Participants were defined as early treatment failures (ETFs) if they developed danger signs or severe malaria on Day 2, Day 3, or Day 4 in the presence of parasitemia, parasitemia on Day 3 with a count higher than the Day 1 count irrespective of axillary temperature, parasitemia on Day 4 with axillary temperature ≥ 37.5°C, or parasitemia on Day 4 with a count equal to or more than 25% of the count on Day 1. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
| Percentage of participants | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|
| Percentage Early Treatment Failure (ETF) | 0.0 (0.0 to 14.3) | 0.0 (0.0 to 13.2) | 0.0 (0.0 to 28.5) | 0.0 (0.0 to 24.7) | 0.0 (0.0 to 3.4) | 0.0 (0.0 to 3.3) |
Participants were defined as late clinical failures (LCFs) if they developed danger signs or severe malaria on any day from Day 5 to Day 43 in the presence of parasitemia without previously meeting any of the criteria of ETF, or if they had parasitemia and an axillary temperature of ≥ 37.5°C on any day from Day 5 to Day 43 without previously meeting any of the criteria of ETF. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
| Percentage of participants | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|
| Percentage Late Clinical Failure (LCF) | 8.7 (1.1 to 28.0) | 0.0 (0.0 to 13.2) | 0.0 (0.0 to 28.5) | 7.7 (0.2 to 36.0) | 8.7 (4.0 to 15.8) | 3.9 (1.1 to 9.7) |
Participants were defined as late parasitological failures (LPFs) if they had parasitemia on any day from Day 8 to Day 43 and an axillary temperature \< 37.5°C without previously meeting any of the criteria of ETF or LCF. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
| Percentage of participants | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|
| Percentage Late Parasitological Failure (LPF) | 19.0 (5.5 to 41.9) | 19.2 (6.6 to 39.4) | 54.5 (23.4 to 83.3) | 16.7 (2.1 to 48.4) | 4.2 (1.2 to 10.4) | 11.2 (5.7 to 19.2) |
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 had to be confirmed by PCR analysis. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
| Participants | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|
| Day 15 | 0 | 0 | 0 | 0 | 0 | 0 |
| Day 29 | 1 | 0 | 0 | 0 | 1 | 1 |
| Day 43 | 1 | 0 | 0 | 1 | 1 | 1 |
New infection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. New infection had to be confirmed by PCR analysis. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
| Participants | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|
| Day 15 | 0 | 0 | 0 | 0 | 0 | 0 |
| Day 29 | 1 | 0 | 2 | 0 | 3 | 4 |
| Day 43 | 3 | 3 | 3 | 2 | 7 | 5 |
Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs. Given the age-independent symptoms of acute malaria, and to increase statistical power, the cohorts 1 and 2 were pooled (cohort 1/2).
| Participants | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|
| Adverse Events | 15 | 13 | 10 | 9 | 74 | 61 |
| Serious Adverse Events | 1 | 0 | 0 | 1 | 0 | 4 |
Cmax is the maximum observed plasma concentration following drug administration. PK parameters are calculated from plasma concentration-time data using non-compartmental methods. Analyte KAF156 is not applicable for Artemether80mg/LUM480mg arm.
| ng/mL | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1-KAF400mg/LUM480mg-QDx3 | Cohort 2-KAF400mg/LUM480mg-QDx3 | Cohort 1-Artemether80mg/LUM480mg | Cohort 2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|---|---|
| KAF156 | 1520 ± 27.1 | 1460 ± 26.5 | 1610 ± 17.7 | 1320 ± 24.6 | 1240 ± 60.4 | 741 ± 56.6 | — | — |
| LUM | 11600 ± 59.1 | 7850 ± 64.4 | 25900 ± 51.1 | 10900 ± 86.7 | 21300 ± 52.5 | 9020 ± 135.5 | 6510 ± 63.3 | 3300 ± 142 |
AUC is the area under the plasma concentration-time curve. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The Artemether80mg/LUM480mg arms (standard of care) involved limited pharmacokinetic sampling at 24, 48, 68, and 168 hours following the first dose administration. In contrast, the KAF156 arms had a more extensive sampling, varying by age group, which included time points at 3, 6, 24, 48, 51, 54, 72, and 168 hours following first dose. Due to the limited sampling in the Artemether80mg/LUM480mg arms, it was not planned (per protocol) to calculate AUC values.
| h*ng/mL | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1-KAF400mg/LUM480mg-QDx3 | Cohort 2-KAF400mg/LUM480mg-QDx3Edit |
|---|---|---|---|---|---|---|
| KAF156 | 45900 ± 21.2 | 44100 ± 30.7 | 53000 ± 29.1 | 44000 ± 27.4 | 44100 ± 66.8 | 25600 ± 71.6 |
| LUM | 389000 ± 60.4 | 207000 ± 86.5 | 934000 ± 49.7 | 342000 ± 80.3 | 970000 ± 59.6 | 383000 ± 182.1 |
Tmax is the time to reach maximum plasma concentration following drug administration. PK parameters are calculated from plasma concentration-time data using non-compartmental methods. The Artemether80mg/LUM480mg arms (standard of care) involved limited pharmacokinetic sampling at 24, 48, 68, and 168 hours following the first dose administration. In contrast, the KAF156 arm had a more extensive sampling, varying by age group, which included time points at 3, 6, 24, 48, 51, 54, 72, and 168 hours following first dose. PK samples for the Artemether80mg/LUM480mg arms were collected around the expected Tmax (at 68 hours, i.e., 8 hours after the last dose, based on the known Tmax of lumefantrine in Coartem) to determine Cmax values; in line with the protocol, separate Tmax values were not calculated.
| hours | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1-KAF400mg/LUM480mg-QDx3 | Cohort 2-KAF400mg/LUM480mg-QDx3 |
|---|---|---|---|---|---|---|
| KAF156 | 3.92 (2.65 to 7.93) | 3.58 (1.35 to 5.88) | 4.46 (3.87 to 5.97) | 4.18 (2.85 to 7.98) | 3.03 (0 to 23.5) | 2.95 (0 to 23.5) |
| LUM | 7.67 (4.02 to 8.12) | 7.7 (0.967 to 8.23) | 7.02 (5.9 to 24.1) | 6.05 (5.05 to 24.2) | 5.97 (0 to 23.9) | 6.02 (0 to 24.4) |
C168h is the plasma concentration at 168h post first dose administration. PK parameters are calculated from plasma concentration-time data using non-compartmental methods. Analyte KAF156 is not applicable for Artemether80mg/LUM480mg arm.
| ng/mL | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1-KAF400mg/LUM480mg-QDx3 | Cohort 2-KAF400mg/LUM480mg-QDx3 | Cohort 1-Artemether80mg/LUM480mg | Cohort 2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|---|---|
| KAF156 | 23.9 ± 38.7 | 21.8 ± 62.5 | 14.9 ± 62.7 | 25.3 ± 55.9 | 24.8 ± 120.8 | 11 ± 87.5 | — | — |
| LUM | 429 ± 50.1 | 189 ± 106.1 | 679 ± 36.5 | 332 ± 73.5 | 1320 ± 92.4 | 574 ± 135.8 | 438 ± 80.9 | 297 ± 89.1 |
Collected over Adverse events were reported from first dose of study treatment until end of study treatment up to a maximum duration of approximately 43 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | 0/25 (0%) | 1/25 (4%) | 12/25 (48%) |
| Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | 0/26 (0%) | 0/26 (0%) | 12/26 (46.2%) |
| Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | 0/11 (0%) | 0/11 (0%) | 10/11 (90.9%) |
| Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | 0/13 (0%) | 1/13 (7.7%) | 9/13 (69.2%) |
| Cohort 1/2-KAF400mg/LUM480mg-QDx3 | 0/110 (0%) | 0/110 (0%) | 69/110 (62.7%) |
| Cohort 1/2-Artemether80mg/LUM480mg | 0/110 (0%) | 4/110 (3.6%) | 55/110 (50%) |
| Event | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|
| Blood bilirubin increasedInvestigations | 1/25 | 0/26 | 0/11 | 1/13 | 0/110 | 1/110 |
| Liver function test increasedInvestigations | 0/25 | 0/26 | 0/11 | 0/13 | 0/110 | 2/110 |
| BronchitisInfections and infestations | 0/25 | 0/26 | 0/11 | 0/13 | 0/110 | 1/110 |
| Event | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1/2-KAF400mg/LUM480mg-QDx3 | Cohort 1/2-Artemether80mg/LUM480mg |
|---|---|---|---|---|---|---|
| MalariaInfections and infestations | 6/25 | 5/26 | 6/11 | 3/13 | 13/110 | 15/110 |
| Electrocardiogram QT prolongedInvestigations | 3/25 | 1/26 | 4/11 | 1/13 | 18/110 | 6/110 |
| VomitingGastrointestinal disorders | 1/25 | 2/26 | 1/11 | 0/13 | 32/110 | 12/110 |
| HypokalaemiaMetabolism and nutrition disorders | 1/25 | 1/26 | 0/11 | 0/13 | 27/110 | 16/110 |
| PyrexiaGeneral disorders | 2/25 | 1/26 | 2/11 | 3/13 | 16/110 | 12/110 |
| HeadacheNervous system disorders | 2/25 | 0/26 | 0/11 | 3/13 | 1/110 | 1/110 |
| NauseaGastrointestinal disorders | 0/25 | 0/26 | 0/11 | 2/13 | 0/110 | 0/110 |
| AnaemiaBlood and lymphatic system disorders | 0/25 | 1/26 | 1/11 | 1/13 | 5/110 | 6/110 |
| DiarrhoeaGastrointestinal disorders | 0/25 | 0/26 | 1/11 | 1/13 | 2/110 | 3/110 |
| ToothacheGastrointestinal disorders | 0/25 | 0/26 | 1/11 | 0/13 | 0/110 | 0/110 |
| Age, Categorical(Participants) | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1-KAF400mg/LUM480mg-QDx3 | Cohort 2-KAF400mg/LUM480mg-QDx3 | Cohort 1-Artemether80mg/LUM480mg | Cohort 2-Artemether80mg/LUM480mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 25 | 26 | 11 | 13 | 70 | 40 | 70 | 40 | 295 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1-KAF400mg/LUM480mg-QDx3 | Cohort 2-KAF400mg/LUM480mg-QDx3 | Cohort 1-Artemether80mg/LUM480mg | Cohort 2-Artemether80mg/LUM480mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 14.08 ± 1.382 | 13.62 ± 1.416 | 14.36 ± 1.859 | 14.85 ± 1.573 | 6.83 ± 2.828 | 1.41 ± 0.454 | 6.49 ± 2.535 | 1.24 ± 0.429 | 7.10 ± 5.069 |
| Sex: Female, Male(Participants) | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1-KAF400mg/LUM480mg-QDx3 | Cohort 2-KAF400mg/LUM480mg-QDx3 | Cohort 1-Artemether80mg/LUM480mg | Cohort 2-Artemether80mg/LUM480mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 15 | 12 | 8 | 4 | 42 | 18 | 30 | 12 | 141 |
| Male | 10 | 14 | 3 | 9 | 28 | 22 | 40 | 28 | 154 |
| Race/Ethnicity, Customized(Participants) | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM240mg-QDx2-Fasted | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fed | Run-in Cohort-KAF400mg/LUM480mg-QDx2-Fasted | Cohort 1-KAF400mg/LUM480mg-QDx3 | Cohort 2-KAF400mg/LUM480mg-QDx3 | Cohort 1-Artemether80mg/LUM480mg | Cohort 2-Artemether80mg/LUM480mg | Total |
|---|---|---|---|---|---|---|---|---|---|
| Black or African American | 25 | 26 | 11 | 13 | 70 | 40 | 70 | 40 | 295 |
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Plan to share: Yes — Novartis is commited 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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.
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Studies of the drug tested here: Ganaplacide