Pharmacokinetics of ganaplacide and lumefantrine in a pediatric population with Plasmodium falciparum uncomplicated malaria, treated with ganaplacide plus lumefantrine solid dispersion formulation: analysis of data from KALUMI, a multinational Phase 2 study

Abstract

Background The new antimalarial combination ganaplacide plus lumefantrine-SDF was shown in a previous phase 2 study to be effective and well-tolerated in the treatment of uncomplicated falciparum malaria in adults, adolescents and children ≥ 2 years old. Here we report pharmacokinetic data from a second phase 2 study, which aimed to optimize the dose regimen and food intake with dosing, and to assess efficacy, safety and pharmacokinetics in children aged 6 months to 2 years with acute uncomplicated falciparum malaria. Methods In this randomized, open-label phase 2 study in uncomplicated falciparum malaria, sequential cohorts of patients aged 2 to C 168h was higher in the ganaplacide plus lumefantrine-SDF group than the artemether-lumefantrine group in both cohorts. Drug exposures were comparable to those in patients treated with ganaplacide 400 mg plus lumefantrine-SDF 960 mg (doses adjusted by body weight range) given under fasted conditions in a previous study. Conclusions Ganaplacide 400 mg plus lumefantrine-SDF 480 mg given with a light meal q.d. for 3 days achieved effective drug exposures in patients with uncomplicated falciparum malaria. Trial registration The study is registered with EudraCT (2021-003583-27) and ClinicalTrials.gov (NCT04546633).

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