This is a Phase 1b, single-cente, randomized, double-blind, placebo-controlled proof-of-concept study evaluating the safety, tolerability, pharmacokinetics and mosquitocidal activity of single oral doses of lotilaner in healthy, adult participants living in Mali.
Male and female volunteers aged 18-55 years of age (inclusive) at the time of signing the Informed Consent.
Total body weight (BW) ≥50 kg, and a body mass index (BMI) of 18-32 kg/m2 (inclusive).
Residence within the study area.
Judged healthy based on a comprehensive clinical assessment, including a detailed medical history and full physical examination.
Evidence of clinically significant, gastrointestinal, cardiac, lung, hepatic, neurologic, psychiatric, rheumatologic, autoimmune, dermatologic, hematological, oncologic, or renal disease by anamnesis, physical examination, and/or laboratory tests.
Known Central Nervous System disorders or a history of seizures.
Any surgery that may affect drug bioavailability (excluding appendectomy and cholecystectomy).
Signs and symptoms of uncomplicated or severe malaria. An asymptomatic Plasmodium infection is not exclusionary.
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Treatment groupsSee each treatment group below.
Medicines for Malaria Venture
Lead sponsor
Radboud University Medical Center
Collaborator
London School of Hygiene and Tropical Medicine
Collaborator
Malaria Research and Training Center, Bamako, Mali
Collaborator