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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
A 600 mg dose of GSK3772701 administered orally, as 4 capsules of 150 mg.
A 900 mg dose of GSK3772701 administered orally, as 6 capsules of 150 mg.
A daily 150 mg dose of GSK3772701 administered orally on Day 1 and Day 2, 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.
Time frame: From the date of informed consent signing (up to 24 hours prior to Day 1) up to Day 40 (end of the follow-up period)
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.
Time frame: From Day 1 up to Day 40
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
A 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.
A daily 50 mg dose of GSK3772701 administered orally on Day 1, Day 2 and Day 3, as 1 capsule.
Time frame: From Day 1 to Day 7
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.
Time frame: From Day 1 to Day 7
Maximum observed concentration (Cmax) of GSK3772701
Time frame: From Day 1 to Day 7
Time to maximum observed drug concentration (Tmax) of GSK3772701
Tmax is defined as time to reach the Cmax.
Time frame: From Day 1 to Day 7
Apparent terminal half-life (t1/2) of GSK3772701
Apparent terminal phase half-life in plasma (and blood), calculated as loge (2)/λz.
Time frame: From Day 1 to Day 7
Trough concentration (Ctau) of GSK3772701 following multiple dose administration
Ctau is defined as the trough/pre-dose concentration after dosing interval, tau.
Time frame: From Day 2 to Day 7
Observed accumulation ratio (R) of GSK3772701 for AUC [AUC(Ro)] following multiple dose administration
AUC-tau (Ro) is defined as the accumulation ratio for AUC(0-tau) comparing last day of dosing to Day 1.
Time frame: From Day 2 or Day 3 to Day 7, compared to Day 1
Observed accumulation ratio of GSK3772701 based on Cmax (RCmax) following multiple doses
Cmax (RCmax) is defined as the accumulation ratio for Cmax comparing last day of dosing to Day 1.
Time frame: From Day 2 or Day 3 to Day 7, compared to Day 1