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.
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.
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Plasmodium infection, i.e., infection with more than one malaria (plasmodium) species (by microscopy; participant to be withdrawn from study treatment if PCR subsequently indicates presence of mixed infection).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.
Sequential
GSK3772701 600 mg
DrugA 600 mg dose of GSK3772701 administered orally, as 4 capsules of 150 mg.
GSK3772701 900 mg
DrugA 900 mg dose of GSK3772701 administered orally, as 6 capsules of 150 mg.
GSK3772701 150 mg
DrugA daily 150 mg dose of GSK3772701 administered orally on Day 1 and Day 2, as 1 capsule.
GSK3772701 400 mg
DrugA daily 400 mg dose of GSK3772701 administered orally on Day 1 and Day 2, as 2 capsules of 150 mg and 1 capsule of 100 mg.
GSK3772701 50 mg
DrugA daily 50 mg dose of GSK3772701 administered orally on Day 1, Day 2 and Day 3, as 1 capsule.
Number of participants with serious adverse events (SAEs) overall, treatment related, and by severity
A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant; abnormal pregnancy outcomes; or any other situation according to medical or scientific judgment. The intensity of SAEs is assessed as per the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicates greater severity. Any = occurrence of the event regardless of intensity grade and treatment relationship. Treatment related = occurrence of the event which, in the investigator's opinion, is related to the administered treatment regardless of the intensity grade.
Number of participants with non-serious AEs overall, treatment related, and by severity
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The intensity of non-serious AEs is assessed using the DAIDS criteria Version 2.1 where grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicates greater severity. Any = occurrence of the event regardless of intensity grade and treatment relationship. Treatment related = occurrence of the event which, in the investigator's opinion, is related to the administered treatment regardless of the intensity grade.
Area under the concentration (AUC) - time curve (AUC[0-t]) of GSK3772701
AUC(0-t) is defined as the area under the concentration-time curve from time zero to the time of the last evaluable concentration.
AUC(0-t) extrapolated to infinity (AUC[0-inf]) of GSK3772701
AUC(0-inf) is defined as the area under the concentration-time curve extrapolated to infinity calculated as: . AUC(0-inf) = AUC(0-t) + C(t) / λz.
Maximum observed concentration (Cmax) of GSK3772701
Time to maximum observed drug concentration (Tmax) of GSK3772701
Tmax is defined as time to reach the Cmax.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
