Novartis Phase 2
Study period:Ongoing.
This study aims to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated P. falciparum malaria. There is unmet medical need for anti-malarial treatment with new mechanism of action to reduce probability of developing resistance, and for duration shorter than 3 days of treatment and/or reduced pill burden.
Objectives
- To determine the effective doses of KAF156 combined with LUM-SDF given daily over 1, 2 or 3 days for treatment of uncomplicated malaria caused by P. falciparum. The primary efficacy endpoint is the polymerase chain reaction (PCR)corrected adequate clinical and parasitological response(ACPR) at Day 29.
- To evaluate the safety and tolerability of KAF156/LUM-SDF.
- To further assess the effect of treatment with KAF156/LUM-SDF by assessing uncorrected ACPR and corrected ACPR at additional time points, as well as fever- and parasite clearance times.
- To assess key pharmacokinetic(PK) parameters of KAF156 and lumefantrine.
