Novartis Pharmaceuticals
This study is to investigate the ability of LXE408 to clear or reduce the level of parasites in the blood of people with chronic Chagas disease. Participants must have chronic Chagas disease without severe organ dysfunction.
This is an interventional, phase 2, PoC (Proof of Concept) randomized, participant- and investigator-blinded, controlled, parallel group study, with 4 treatment arms. The purpose of this study is to assess the efficacy (anti-parasitological activity), safety, PK (pharmacokinetics), and PD (pharmacodynamics) of LXE408 in participants with CICD (chronic indeterminate Chagas disease) and chronic Chagas disease without severe cardiac or gastrointestinal dysfunction compared to placebo and to benznidazole.
Inclusion Criteria: * Male or female participants aged ≥ 18 years to ≤ 60 years old * Confirmed diagnosis of T. cruzi infection * History that participant has been determined to be in chronic phase of CD * Written informed consent must be obtained before any assessment is performed, and participants should express understanding of the consent form and the study * Participants must be considered by the investigator eligible for and able to comply with local prescribing information for benznidazole * Ability and willingness to communicate well with the investigator/study site and comply with re…
LXE408 administered by oral route
Placebo administered by oral route
Benznidazole administered by oral route (administered as standard of care)