A Phase 2 interventional study of Artefenomel (OZ439) and Ferroquine (SSR97193) in Plasmodium Falciparum Infection, sponsored by Sanofi. Completed at 7 sites in 5 countries. Open to participants aged 14 Years to 69 Years. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
Primary Objective:
To show the contribution of artefenomel (OZ439) to the clinical and parasiticidal effect of OZ439/Ferroquine (FQ) combination by analyzing exposure-response of OZ439 measured by Day 28 polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) for the effect and the area under the curve (AUC) of OZ439 as pharmacokinetic (PK) predictor.
Secondary Objectives:
The duration of the study was up to 32 days, including up to 1 day screening period before the single-dose treatment, 5 days of post-treatment surveillance (included 2 to 4 days hospitalization) and 24±2 days follow-up period.
Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Participants (14-69 years old inclusive) with body weight within 35 and 90 kilograms (kg), with uncomplicated Plasmodium falciparum (P. falciparum) malaria, with a fever as defined with axillary temperature greater than or equal to (>=) 37.5 degree Celsius (°C) or oral/ rectal/ tympanic temperature >=38°C or history of fever in the previous 24 hours (history of fever was documented), with a mono-infection with P. falciparum and parasitemia (microscopically, blood smear) >= 3,000 and less than or equal to (\<=) 50,000 asexual parasites per microliter of blood.
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition.
Drug: Ferroquine (SSR97193)
On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 300 mg oral suspension.
Drug: Artefenomel (OZ439) · Drug: Ferroquine (SSR97193)
On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 600 mg oral suspension.
Drug: Artefenomel (OZ439) · Drug: Ferroquine (SSR97193)
On Day 0, participants received orally a single dose of FQ 400 mg (4 capsules of 100 mg) in fasted condition followed by OZ439 1000 mg oral suspension.
Drug: Artefenomel (OZ439) · Drug: Ferroquine (SSR97193)
Pharmaceutical form: Granules for oral suspension Route of administration: Oral
Pharmaceutical form: Capsule Route of administration: Oral
Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 28 (ACPR28)
ACPR:absence of parasitemia at Day 28, irrespective of axillary temperature(AT), participants not meeting any criteria of early therapy failure(ETF):Danger signs(DS)/symptoms of complicated(SoC)/severe malaria(SM) at Day 1, 2 or 3 in presence of parasitemia, concomitant to at least 1 positive parasitemia;or parasitemia on Day 2 \>Day 0 irrespective of AT;or parasitemia on Day 3 with AT\>=37.5 degree Celsius (°C);or parasitemia count on Day 3 \>=25 percent (%) on Day 0, or late clinical failure (LCF):DS/SM in presence of parasitemia between Day 4 and 28,concomitant to at least one positive parasitemia;or presence of parasitemia and AT\>=37.5°C on Day 4 to Day 28, or late parasitological failure(LPF):presence of parasitemia between Day 7 and 28 and AT\<37.5°C and without rescue therapy. PCR-corrected ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with reinfection.
Time frame: Day 28
Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28
ACPR: absence of parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS/SoC/SM at Day 1, 2 or 3 in presence of parasitemia, concomitant to at least 1 positive parasitemia; or parasitemia on Day 2 \> Day 0 irrespective of AT; or parasitemia on Day 3 with AT \>=37.5°C; or parasitemia count on Day 3 \>=25% on Day 0, or LCF: DS/SM in presence of parasitemia between Day 4 and 28, concomitant to at least one positive parasitemia; or presence of parasitemia and AT\>=37.5°C on Day 4 to Day 28, or LPF: presence of parasitemia between Day 7 and 28 and AT\<37.5°C or having rescue therapy for malaria. PCR-corrected ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with re-infection, whereas crude ACPR does not distinguish reinfection (new clone of parasite) or recrudescence.
Time frame: Day 28
Parasitemia: Change From Baseline in Number of Parasites Per Microliter of Blood at 6, 12, 18, 24, 30, 36, 48, 72, 96, 120, 144 and 168 Hours
Parasitemia (quantitative content of parasites present in the blood) at baseline until Day 7 (i.e. 168 hours) was assessed by optical microscope.
Time frame: Baseline, 6, 12, 18, 24, 30, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Observed Parasite Reduction Ratio (PRR) at 24 Hours, 48 Hours, and 72 Hours
The observed PRR was defined as the ratio of the number of parasites at time t=0 (baseline) divided by the parasite count at each specified time t (post-treatment). If the post dose parasite count = 0 (due to a negative parasitemia) then a value of 1 parasite per microliter was imputed to allow a parasite reduction ratio calculation.
Time frame: Baseline, 24, 48 and 72 hours post-dose
Time to 50% and 99% Parasite Reduction
Time to 50% and 99% parasite reduction was defined as time needed for the parasitemia (quantitative content of parasites present in blood) to be reduced to 50% and 99% of the initial value, respectively.
Time frame: Up to Day 28
Parasite Clearance Time (PCT)
PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites by microscopy). This first negative film was confirmed by a second negative film which was taken \>=6 to \<=12 hours of the first film. If the second film was performed \<6 hours or \>12 hours of the first film, then the parasite clearance was confirmed or invalidated by the third (thick) film following the second one, whatever the timing of this third film: If the third film was negative, then the clearance was considered confirmed and if the third film was positive, then the clearance was invalidated. Kaplan-Meier method was used for the estimation.
Time frame: From the start of study drug administration up to the time of the first negative blood film (up to Day 28)
Parasite Clearance Rate
Parasite clearance rate (k) is the minus slope of the natural logarithm parasitemia versus time linear relationship, after exclusion of outliers, lag phase and Tail, using the worldwide antimalarial resistance network, Parasite Clearance Estimator.
Time frame: Up to Day 28
Time to Re-emergence
Time to re-emergence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection irrespective of genotype. Re-emergence was confirmed by microscopy (positive blood smear). Participants with confirmed parasite clearance were included in the analysis and Kaplan-Meier method was used for estimation.
Time frame: Up to Day 28
Time to Recrudescence
Time to recrudescence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline. Recrudescence was confirmed by PCR analysis. Participants with confirmed parasite clearance were included in the analysis and Kaplan-Meier method was used for estimation.
Time frame: Up to Day 28
Time to Re-infection
Time to re-infection (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype that differed from that of parasites present at Baseline. Re-infection was confirmed by PCR analysis. Participants with confirmed parasite clearance were involved in the analysis and Kaplan-Maier method was used for estimation.
Time frame: Up to Day 28
Time Elapsed Below the Limit of Quantification (LOQ) of Parasitemia
The time elapsed below LOQ (LOQ expressed in parasites/microliter) of parasitemia (quantitative content of parasites present in the blood) was defined as the time (in days) for which no parasites were seen i.e., time corresponding to PCT, up to the time of occurrence of a new malaria infection or recrudescence. If there was no occurrence of a new malaria infection or recrudescence, then this was the time corresponding to the first negative thick blood film, until the end of study. PCT (k) is the minus slope of the natural logarithm parasitemia versus time linear relationship, after exclusion of outliers, lag phase and Tail, using the worldwide antimalarial resistance network, Parasite clearance estimator. Participants with confirmed parasite clearance were involved in the analysis and Kaplan-Meier method was used for estimation.
Time frame: Up to Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)
An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. SAEs were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment phase that was defined as the time from the start of study drug up to the Day 28. AE of special interest (AESI) was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.
Time frame: From Baseline up to Day 28
Pharmacokinetics (PK): Concentration of OZ439 in Plasma
Concentrations of OZ439 in plasma was analyzed by liquid chromatography tandem mass spectroscopy (LC-MS/MS). The lower limit of quantification (LLOQ) was 1 nanograms per milliliter for analysis of OZ439. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
Time frame: 1, 2, 4, 6, 12, 24, 48, 72, 120, 168 and 336 hours post-dose
Pharmacokinetics: Concentration of FQ and Its Active Metabolite SSR97213 in Blood
Concentrations of FQ and SSR97213 in blood was analyzed by LC-MS/MS. The LLOQ was 5 nanograms per milliliter for analysis of FQ and SSR97213.
Time frame: 1, 4, 6, 8, 12, 24, 72, 168, 336 and 672 hours post-dose
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Artefenomel
Cmax is the maximum observed plasma concentration of Artefenomel. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
Time frame: Pre-dose, 1, 2, 4, 6, 12, 24, 48, 72, 120, 168 and 336 hours post-dose
Pharmacokinetics: Time to Reach Maximum Plasma Concentration (Tmax) of Artefenomel
tmax is the time taken by the drug to reach the maximum plasma concentration. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
Time frame: Pre-dose, 1, 2, 4, 6, 12, 24, 48, 72, 120, 168 and 336 hours post-dose
Pharmacokinetics: Plasma Concentration at 168 Hours Post-dose (C168h) of Artefenomel
The observed plasma concentration of artefenomel post 168 hours of drug administration. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
Time frame: At 168 hours post-dose
Pharmacokinetics: Area Under the Concentration Curve (AUC) Form Time 0 to Infinity (AUC0-inf]) of Artefenomel
Area under the plasma concentration versus time curve from time 0 to infinity. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
Time frame: Pre-dose, 1, 2, 4, 6, 12, 24, 48, 72, 120, 168 and 336 hours post-dose
Pharmacokinetics: Terminal Half-life (t1/2) of Artefenomel
Terminal t1/2 is defined as the time required for the plasma concentration of a drug to decrease by half of its initial concentration. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
Time frame: Pre-dose, 1, 2, 4, 6, 12, 24, 48, 72, 120, 168 and 336 hours post-dose
Pharmacokinetics: Maximum Observed Plasma Concentration of Ferroquine and Its Active Metabolite SSR97213
Cmax is the maximum observed plasma concentration of Ferroquine.
Time frame: Pre-dose, 1, 4, 6, 8, 12, 24, 72, 168, 336 and 672 hours post-dose
Pharmacokinetics: Time to Reach Maximum Plasma Concentration of Ferroquine and Its Active Metabolite SSR97213
tmax is the time taken by the drug to reach the maximum plasma concentration.
Time frame: Pre-dose, 1, 4, 6, 8, 12, 24, 72, 168, 336 and 672 hours post-dose
Pharmacokinetics: Plasma Concentration at 168 Hours Post-dose of Ferroquine and Its Active Metabolite SSR97213
The observed plasma concentration of FQ and SSR97213 post 168 hours of FQ administration.
Time frame: At 168 hours post-dose
Pharmacokinetics: Area Under the Concentration Curve Form Time 0 to Day 28 (AUC0-28) of Ferroquine and Its Active Metabolite SSR97213
Area under the plasma concentration versus time curve from time 0 to Day 28 (i.e. 672 hours).
Time frame: Pre-dose, 1, 4, 6, 8, 12, 24, 72, 168, 336 and 672 hours post-dose
Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity of Ferroquine and Its Active Metabolite SSR97213
Area under the plasma concentration versus time curve from time 0 to infinity.
Time frame: Pre-dose, 1, 4, 6, 8, 12, 24, 72, 168, 336 and 672 hours post-dose
Pharmacokinetics: Terminal Half-life of Ferroquine
Terminal t1/2 is defined as the time required for the plasma concentration of a drug to decrease by half of its initial concentration.
Time frame: Pre-dose, 1, 4, 6, 8, 12, 24, 72, 168, 336 and 672 hours post-dose
Study was conducted at 7 active sites in 5 countries. Total of 448 participants were screened between 11 September 2018 and 09 October 2019, of which 140 were randomized to 1 of 4 treatment arms and those who failed to meet inclusion criteria were considered as screen failure.
| Milestone | Ferroquine (FQ) 400 Milligram (mg) | Ferroquine 400 mg + Artefenomel (OZ439) 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Started | 35 | 36 | 36 | 33 |
| Completed | 35 | 36 | 36 | 33 |
| Not completed | 0 | 0 | 0 | 0 |
ACPR:absence of parasitemia at Day 28, irrespective of axillary temperature(AT), participants not meeting any criteria of early therapy failure(ETF):Danger signs(DS)/symptoms of complicated(SoC)/severe malaria(SM) at Day 1, 2 or 3 in presence of parasitemia, concomitant to at least 1 positive parasitemia;or parasitemia on Day 2 \>Day 0 irrespective of AT;or parasitemia on Day 3 with AT\>=37.5 degree Celsius (°C);or parasitemia count on Day 3 \>=25 percent (%) on Day 0, or late clinical failure (LCF):DS/SM in presence of parasitemia between Day 4 and 28,concomitant to at least one positive parasitemia;or presence of parasitemia and AT\>=37.5°C on Day 4 to Day 28, or late parasitological failure(LPF):presence of parasitemia between Day 7 and 28 and AT\<37.5°C and without rescue therapy. PCR-corrected ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with reinfection.
| percentage of participants | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitological Response (ACPR) at Day 28 (ACPR28) | 80.8 (62.1 to 91.5) | 90.3 (75.1 to 96.7) | 90.9 (76.4 to 96.9) | 87.1 (71.1 to 94.9) |
ACPR: absence of parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS/SoC/SM at Day 1, 2 or 3 in presence of parasitemia, concomitant to at least 1 positive parasitemia; or parasitemia on Day 2 \> Day 0 irrespective of AT; or parasitemia on Day 3 with AT \>=37.5°C; or parasitemia count on Day 3 \>=25% on Day 0, or LCF: DS/SM in presence of parasitemia between Day 4 and 28, concomitant to at least one positive parasitemia; or presence of parasitemia and AT\>=37.5°C on Day 4 to Day 28, or LPF: presence of parasitemia between Day 7 and 28 and AT\<37.5°C or having rescue therapy for malaria. PCR-corrected ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with re-infection, whereas crude ACPR does not distinguish reinfection (new clone of parasite) or recrudescence.
| percentage of participants | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28 | 64.5 (46.9 to 78.9) | 81.8 (65.6 to 91.4) | 77.8 (61.9 to 88.3) | 78.1 (61.2 to 89) |
Parasitemia (quantitative content of parasites present in the blood) at baseline until Day 7 (i.e. 168 hours) was assessed by optical microscope.
| parasites per microliter | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Baseline | 17496.0 ± 11889.55 | 18799.6 ± 13559.14 | 15171.9 ± 13012.53 | 20546.8 ± 13835.31 |
| Change from baseline at 6 hours post-dose | -1349.3 ± 11331.78 | -96.9 ± 11699.28 | 8515.4 ± 44264.14 | 893.2 ± 21052.27 |
| Change from baseline at 12 hours post-dose | -5721.5 ± 12441.39 | -11471.6 ± 13399.27 | -4156.6 ± 34663.71 | -11319.4 ± 15490.43 |
| Change from baseline at 18 hours post-dose | -9181.2 ± 11892.89 | -17021.4 ± 13015.29 | -9447.5 ± 32303.36 | -18281.9 ± 13796.37 |
| Change from baseline at 24 hours post-dose | -14238.4 ± 11402.25 | -17939.0 ± 13061.86 | -10674.6 ± 29868.45 | -19461.9 ± 14049.02 |
| Change from baseline at 30 hours post-dose | -16571.1 ± 12354.88 | -19110.5 ± 13556.35 | -13299.6 ± 17452.15 | -19657.5 ± 14393.75 |
| Change from baseline at 36 hours post-dose | -17036.9 ± 12307.57 | -18792.2 ± 13548.16 | -14573.9 ± 13623.86 | -19587.9 ± 14051.82 |
| Change from baseline at 48 hours post-dose | -17595.3 ± 12037.99 | -17706.1 ± 13389.25 | -14542.3 ± 13547.11 | -20327.7 ± 13739.17 |
| Change from baseline at 72 hours post-dose | -18231.8 ± 11801.65 | -18396.3 ± 13091.47 | -15333.7 ± 13382.41 | -20314.2 ± 13980.12 |
| Change from baseline at 96 hours post-dose | -18287.6 ± 12011.77 | -19024.7 ± 13200.22 | -15258.5 ± 13191.95 | -20662.0 ± 14108.54 |
| Change from baseline at 120 hours post-dose | -19280.0 ± 12145.86 | -19024.7 ± 13200.22 | -15265.3 ± 13190.14 | -20350.4 ± 14010.21 |
| Change from baseline at 144 hours post-dose | -18526.0 ± 11889.52 | -19023.3 ± 13198.28 | -15254.5 ± 13190.39 | -20029.7 ± 14121.74 |
| Change from baseline at 168 hours post-dose | -18962.8 ± 11813.20 | -18922.2 ± 13141.19 | -15268.5 ± 13388.49 | -20349.5 ± 14010.98 |
The observed PRR was defined as the ratio of the number of parasites at time t=0 (baseline) divided by the parasite count at each specified time t (post-treatment). If the post dose parasite count = 0 (due to a negative parasitemia) then a value of 1 parasite per microliter was imputed to allow a parasite reduction ratio calculation.
| ratio | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| At Hour 24 | 638.436 ± 2013.8609 | 5921.197 ± 11566.1520 | 5715.046 ± 9364.8892 | 7929.720 ± 12675.8348 |
| At Hour 48 | 9709.093 ± 13987.7127 | 17594.700 ± 13521.9507 | 13120.409 ± 13182.3022 | 19328.057 ± 14392.7604 |
| At Hour 72 | 15655.447 ± 12806.4644 | 18069.583 ± 13409.1341 | 14561.409 ± 13657.0665 | 19125.715 ± 14516.8397 |
Time to 50% and 99% parasite reduction was defined as time needed for the parasitemia (quantitative content of parasites present in blood) to be reduced to 50% and 99% of the initial value, respectively.
| hours | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Time to 50% Parasite reduction | 14.07 ± 5.604 | 7.74 ± 4.636 | 7.78 ± 3.786 | 9.47 ± 7.976 |
| Time to 99% Parasite reduction | 36.92 ± 9.988 | 19.33 ± 6.107 | 18.34 ± 5.523 | 22.95 ± 17.069 |
PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites by microscopy). This first negative film was confirmed by a second negative film which was taken \>=6 to \<=12 hours of the first film. If the second film was performed \<6 hours or \>12 hours of the first film, then the parasite clearance was confirmed or invalidated by the third (thick) film following the second one, whatever the timing of this third film: If the third film was negative, then the clearance was considered confirmed and if the third film was positive, then the clearance was invalidated. Kaplan-Meier method was used for the estimation.
| hours | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Parasite Clearance Time (PCT) | 56.1 (48.0 to 72.0) | 30.0 (30.0 to 30.0) | 30.0 (24.1 to 30.1) | 30.0 (24.0 to 30.0) |
Parasite clearance rate (k) is the minus slope of the natural logarithm parasitemia versus time linear relationship, after exclusion of outliers, lag phase and Tail, using the worldwide antimalarial resistance network, Parasite Clearance Estimator.
| 1 per hour | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Parasite Clearance Rate | 0.1956 ± 0.07627 | 0.3609 ± 0.09963 | 0.3962 ± 0.11983 | 0.3581 ± 0.12484 |
Time to re-emergence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection irrespective of genotype. Re-emergence was confirmed by microscopy (positive blood smear). Participants with confirmed parasite clearance were included in the analysis and Kaplan-Meier method was used for estimation.
| days | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Time to Re-emergence | NA (28.0 to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
Time to recrudescence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline. Recrudescence was confirmed by PCR analysis. Participants with confirmed parasite clearance were included in the analysis and Kaplan-Meier method was used for estimation.
| days | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Time to Recrudescence | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
Time to re-infection (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype that differed from that of parasites present at Baseline. Re-infection was confirmed by PCR analysis. Participants with confirmed parasite clearance were involved in the analysis and Kaplan-Maier method was used for estimation.
| days | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Time to Re-infection | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
The time elapsed below LOQ (LOQ expressed in parasites/microliter) of parasitemia (quantitative content of parasites present in the blood) was defined as the time (in days) for which no parasites were seen i.e., time corresponding to PCT, up to the time of occurrence of a new malaria infection or recrudescence. If there was no occurrence of a new malaria infection or recrudescence, then this was the time corresponding to the first negative thick blood film, until the end of study. PCT (k) is the minus slope of the natural logarithm parasitemia versus time linear relationship, after exclusion of outliers, lag phase and Tail, using the worldwide antimalarial resistance network, Parasite clearance estimator. Participants with confirmed parasite clearance were involved in the analysis and Kaplan-Meier method was used for estimation.
| days | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Time Elapsed Below the Limit of Quantification (LOQ) of Parasitemia | 25.0 (23.0 to 26.0) | 26.0 (26.0 to 27.0) | 26.5 (26.0 to 27.0) | 26.0 (26.0 to 27.0) |
An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. SAEs were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment phase that was defined as the time from the start of study drug up to the Day 28. AE of special interest (AESI) was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.
| Participants | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| Any TEAE | 18 | 21 | 24 | 24 |
| Any treatment-emergent SAE | 0 | 0 | 1 | 0 |
| Any treatment-emergent AESI | 0 | 1 | 0 | 1 |
| Any TEAE led to treatment discontinuation | 0 | 0 | 0 | 0 |
| Any TEAE led to death | 0 | 0 | 0 | 0 |
Concentrations of OZ439 in plasma was analyzed by liquid chromatography tandem mass spectroscopy (LC-MS/MS). The lower limit of quantification (LLOQ) was 1 nanograms per milliliter for analysis of OZ439. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
| nanograms per milliliter | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|
| 1 hour post-dose | 88.641 ± 104.631 | 149.199 ± 87.153 | 188.423 ± 82.588 |
| 2 hours post-dose | 269.075 ± 59.803 | 450.218 ± 58.642 | 655.851 ± 58.311 |
| 4 hours post-dose | 349.134 ± 54.880 | 576.673 ± 54.357 | 978.649 ± 60.263 |
| 6 hours post-dose | 234.375 ± 52.902 | 478.929 ± 87.523 | 865.581 ± 75.154 |
| 12 hours post-dose | 92.614 ± 60.229 | 164.028 ± 99.433 | 369.335 ± 85.243 |
| 24 hours post-dose | 17.526 ± 65.757 | 48.257 ± 107.605 | 84.167 ± 78.221 |
| 48 hours post-dose | 6.097 ± 54.492 | 14.611 ± 95.627 | 29.554 ± 83.028 |
| 72 hours post-dose | 3.224 ± 50.406 | 8.162 ± 77.493 | 16.665 ± 83.936 |
| 120 hours post-dose | 2.144 ± 39.859 | 5.339 ± 61.816 | 8.596 ± 77.245 |
| 168 hours post-dose | 1.745 ± 38.466 | 3.408 ± 73.232 | 5.903 ± 78.608 |
| 336 hours post-dose | 1.227 ± 19.402 | 1.970 ± 66.212 | 3.149 ± 58.029 |
Concentrations of FQ and SSR97213 in blood was analyzed by LC-MS/MS. The LLOQ was 5 nanograms per milliliter for analysis of FQ and SSR97213.
| nanograms per milliliter | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| 1 hour post-dose: FQ | 36.094 ± 80.476 | 27.214 ± 79.000 | 21.165 ± 55.491 | 26.599 ± 95.999 |
| 1 hour post-dose: SSR97213 | 13.209 ± 54.030 | 10.375 ± 15.713 | 6.161 ± 9.504 | 6.805 ± 28.203 |
| 4 hours post-dose: FQ | 64.934 ± 87.235 | 100.569 ± 61.578 | 79.656 ± 74.707 | 97.007 ± 72.230 |
| 4 hours post-dose: SSR97213 | 20.079 ± 90.358 | 29.632 ± 49.701 | 18.377 ± 98.310 | 17.559 ± 68.694 |
| 6 hours post-dose: FQ | 69.005 ± 75.045 | 92.657 ± 50.449 | 84.803 ± 75.544 | 95.062 ± 126.388 |
| 6 hours post-dose: SSR97213 | 23.170 ± 82.875 | 28.098 ± 53.438 | 25.954 ± 88.481 | 20.687 ± 70.211 |
| 8 hours post-dose: FQ | 64.293 ± 70.724 | 82.639 ± 49.891 | 78.196 ± 72.454 | 82.990 ± 69.989 |
| 8 hours post-dose: SSR97213 | 25.131 ± 66.944 | 29.319 ± 48.679 | 25.304 ± 78.822 | 20.299 ± 63.388 |
| 12 hours post-dose: FQ | 50.621 ± 57.540 | 68.384 ± 50.887 | 59.106 ± 70.461 | 71.743 ± 61.238 |
| 12 hours post-dose: SSR97213 | 19.957 ± 61.856 | 24.385 ± 48.408 | 20.615 ± 77.739 | 18.203 ± 64.197 |
| 24 hours post-dose: FQ | 44.351 ± 52.316 | 53.211 ± 48.834 | 47.568 ± 61.373 | 51.250 ± 75.940 |
| 24 hours post-dose: SSR97213 | 18.874 ± 56.412 | 22.967 ± 55.037 | 19.826 ± 70.907 | 16.763 ± 69.091 |
| 72 hours post-dose: FQ | 25.343 ± 35.315 | 31.161 ± 47.829 | 31.373 ± 70.287 | 29.792 ± 76.912 |
| 72 hours post-dose: SSR97213 | 16.757 ± 46.038 | 20.059 ± 45.134 | 21.315 ± 68.366 | 17.756 ± 82.612 |
| 168 hours post-dose: FQ | 16.973 ± 39.627 | 20.524 ± 39.625 | 21.543 ± 63.679 | 21.322 ± 62.951 |
| 168 hours post-dose: SSR97213 | 16.308 ± 52.300 | 19.196 ± 46.115 | 20.463 ± 55.587 | 19.108 ± 62.123 |
| 336 hours post-dose: FQ | 10.543 ± 36.770 | 11.678 ± 38.490 | 12.469 ± 48.236 | 11.263 ± 82.611 |
| 336 hours post-dose: SSR97213 | 13.612 ± 45.485 | 14.797 ± 46.036 | 15.647 ± 47.974 | 13.686 ± 72.213 |
| 672 hours post-dose: FQ | 6.737 ± 18.832 | 7.623 ± 28.348 | 7.601 ± 29.047 | 7.342 ± 53.998 |
| 672 hours post-dose: SSR97213 | 9.751 ± 41.862 | 10.324 ± 33.482 | 10.977 ± 34.251 | 12.014 ± 59.403 |
Cmax is the maximum observed plasma concentration of Artefenomel. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
| nanograms per milliliter | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|
| Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Artefenomel | 277.3 ± 169 | 488.3 ± 232 | 920.6 ± 77 |
tmax is the time taken by the drug to reach the maximum plasma concentration. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
No measurements were reported for this outcome.
The observed plasma concentration of artefenomel post 168 hours of drug administration. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
| nanograms per milliliter | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|
| Pharmacokinetics: Plasma Concentration at 168 Hours Post-dose (C168h) of Artefenomel | 0.9251 ± 110 | 2.152 ± 202 | 4.445 ± 165 |
Area under the plasma concentration versus time curve from time 0 to infinity. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
| micrograms*hour per milliliter | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) Form Time 0 to Infinity (AUC0-inf]) of Artefenomel | 3.269 ± 113 | 6.46 ± 181 | 13.05 ± 114 |
Terminal t1/2 is defined as the time required for the plasma concentration of a drug to decrease by half of its initial concentration. Data for this outcome measure was not planned to be collected and analyzed for "Ferroquine 400 mg" arm, since artefenomel was not administered.
No measurements were reported for this outcome.
Cmax is the maximum observed plasma concentration of Ferroquine.
| nanograms per milliliter | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| FQ | 80.99 ± 61 | 79.95 ± 93 | 72.64 ± 88 | 82.45 ± 95 |
| SSR97213 | 24.58 ± 61 | 22.65 ± 83 | 19.14 ± 99 | 19.76 ± 78 |
tmax is the time taken by the drug to reach the maximum plasma concentration.
No measurements were reported for this outcome.
The observed plasma concentration of FQ and SSR97213 post 168 hours of FQ administration.
| nanograms per milliliter | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| FQ | 15.86 ± 44 | 18.32 ± 42 | 18.69 ± 52 | 17.83 ± 60 |
| SSR97213 | 16.15 ± 51 | 16.03 ± 68 | 15.2 ± 78 | 14.95 ± 86 |
Area under the plasma concentration versus time curve from time 0 to Day 28 (i.e. 672 hours).
| micrograms*hour per milliliter | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| FQ | 8.874 ± 42 | 10.33 ± 40 | 10.13 ± 51 | 10.14 ± 56 |
| SSR97213 | 8.878 ± 48 | 9.051 ± 56 | 8.483 ± 68 | 8.487 ± 71 |
Area under the plasma concentration versus time curve from time 0 to infinity.
| micrograms*hour per milliliter | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| FQ | 15.5 ± 47 | 17.81 ± 43 | 16.3 ± 63 | 16.87 ± 59 |
| SSR97213 | 19.58 ± 53 | 20.09 ± 48 | 17.94 ± 69 | 18.32 ± 68 |
Terminal t1/2 is defined as the time required for the plasma concentration of a drug to decrease by half of its initial concentration.
No measurements were reported for this outcome.
Collected over From Baseline up to Day 28. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ferroquine 400 mg | 0/35 (0%) | 0/35 (0%) | 13/35 (37.1%) |
| Ferroquine 400 mg + Artefenomel 300 mg | 0/36 (0%) | 0/36 (0%) | 17/36 (47.2%) |
| Ferroquine 400 mg + Artefenomel 600 mg | 0/36 (0%) | 1/36 (2.8%) | 17/36 (47.2%) |
| Ferroquine 400 mg + Artefenomel 1000 mg | 0/33 (0%) | 0/33 (0%) | 22/33 (66.7%) |
| Event | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| MalariaInfections and infestations | 0/35 | 0/36 | 1/36 | 0/33 |
| Event | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg |
|---|---|---|---|---|
| VomitingGastrointestinal disorders | 3/35 | 3/36 | 5/36 | 10/33 |
| HeadacheNervous system disorders | 3/35 | 6/36 | 1/36 | 7/33 |
| MalariaInfections and infestations | 7/35 | 6/36 | 7/36 | 6/33 |
| PyrexiaGeneral disorders | 0/35 | 2/36 | 1/36 | 4/33 |
| DizzinessNervous system disorders | 0/35 | 0/36 | 2/36 | 4/33 |
| Abdominal painGastrointestinal disorders | 1/35 | 4/36 | 0/36 | 2/33 |
| DiarrhoeaGastrointestinal disorders | 0/35 | 1/36 | 0/36 | 2/33 |
| NauseaGastrointestinal disorders | 1/35 | 1/36 | 2/36 | 2/33 |
| RhinitisInfections and infestations | 0/35 | 1/36 | 2/36 | 2/33 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/35 | 0/36 | 0/36 | 0/33 |
Analysis was performed on all randomized participants.
| Age, Continuous(years) | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg | Total |
|---|---|---|---|---|---|
| Mean | 25.4 ± 13.20 | 21.8 ± 11.49 | 20.7 ± 8.57 | 22.2 ± 11.28 | 22.5 ± 11.26 |
| Sex: Female, Male(Participants) | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg | Total |
|---|---|---|---|---|---|
| Female | 23 | 28 | 26 | 20 | 97 |
| Male | 12 | 8 | 10 | 13 | 43 |
| Race (NIH/OMB)(Participants) | Ferroquine 400 mg | Ferroquine 400 mg + Artefenomel 300 mg | Ferroquine 400 mg + Artefenomel 600 mg | Ferroquine 400 mg + Artefenomel 1000 mg | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 35 | 36 | 35 | 33 | 139 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Studies of the drugs tested here: Artefenomel · Ferroquine