About this trial
The study will evaluate the safety and efficacy of a new antimalarial drug GSK3772701 (a pyrrolidinamide), using different doses and treatment durations, in adult participants with uncomplicated Plasmodium (P.) falciparum malaria.
Eligibility criteria
Qualifiers
Male and female patients aged 18 to 65 years.
Fever, as defined by axillary temperature >=37.5°C or oral/tympanic temperature >=38°C and,
Microscopically confirmed P. falciparum malaria parasite mono-infection,
A parasite count between 2,000 to 60,000 asexual parasite count/µL of blood for P. falciparum.
Disqualifiers
Patients with signs and symptoms of severe/complicated malaria according to the WHO 2024 Criteria.
Mixed Plasmodium infection, i.e., infection with more than one malaria (plasmodium) species (by microscopy; participant to be withdrawn from study treatment if PCR subsequently indicates presence of mixed infection).
Abnormal values: QTcF >450 msec or QTcF >480 msec for patients with bundle branch block.
Any clinically significant ECG abnormalities at Screening unrelated to malaria (including but not limited to, second degree AV block (Mobitz Type 2), complete heart block, ST changes, atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia, prolonged QT interval.
Trial design
Treatments tested in this trial
- GSK3772701 600 mg
- GSK3772701 900 mg
- GSK3772701 150 mg
- GSK3772701 400 mg
- GSK3772701 50 mg