A Randomized, Double-blind, Phase IIb Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine (FQ) With Artefenomel (OZ439) in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
A Randomized, Double-blind, Phase IIb Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine (FQ) With Artefenomel (OZ439) in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
Primary Objective:
To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children.
Secondary Objectives:
To evaluate the efficacy of OZ439/FQ:
To evaluate the safety and tolerability of OZ439/FQ in adults and children.
To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood.
To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.
Total duration was 63 days for each participant.
Inclusion criteria:
Male or female participant aged greater than (>) 6 months old and <70 years old:
Body weight >=5 kg and <=90 kg.
Presence of mono-infection by Plasmodium falciparum with:
Informed consent form signed by the participant or by the legally acceptable representative of the minor participant.
Exclusion criteria:
Presence of severe malaria.
Anti-malarial treatment:
Known history or evidence of clinically significant disorders.
Previous treatment within 5 times the half-life or within the last 14 days, whichever the longest which are: P-glycoprotein substrates, Cytochrome P450 (CYP) 2D6 main substrates and/or strong CYP2C or CYP3A inhibitors and/or moderate inhibitors but inhibiting both CYP2C and CYP3A and/or CYP inducers.
Mixed plasmodium infection.
Severe vomiting.
Severe malnutrition.
Laboratory parameters with clinically significant abnormalities and/or reaching critical values. For Liver Function Test. Aspartate aminotransferase (>2 [upper limit of normal] ULN), or alanine aminotransferase (>2 ULN) or total bilirubin >1.5 ULN.
Presence of Hepatitis A Immunoglobulin M, Hepatitis B surface antigen or Hepatitis C antibody.
Had received an investigational drug within the past 4 weeks.
Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance.
Measles and yellow fever vaccine injection within the last 15 days and or planned for the 28 days after randomization.
Female participant of child bearing potential not willing to use an effective contraceptive(s) method(s) for the duration of the study.
Positive serum or urine beta-human chorionic gonadotropin pregnancy test at study screening for female participants of childbearing potential.
Breastfeeding women.
Male participant having a partner of child bearing potential not willing to use an effective method of birth control during the study treatment period.
Splenectomized participants or presence of surgical scar on left hypochondrium. Participant unable to drink.
Known history of hypersensitivity, allergic or anaphylactoid reactions to ferroquine or other amino-quinolines or to OZ439 or OZ277 or to any of the excipients.
Family history of sudden death or of congenital prolongation of the Corrected QT (QTc) interval or known congenital prolongation of the QTc interval or any clinical condition known to prolong the QTc interval e.g., participants with a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.
QTc using Fridericia's formula >450 millisecond at screening or pre-dose.
Hypokalemia (<3.5 millimoles per liter [mmol/L]), hypocalcemia (<2.0 mmol/L) or hypomagnesemia (<0.5 mmol/L) at screening or pre-dose.
Any treatment known to induce a lengthening of QT interval.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Comoé, Burkina Faso