Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]-GSK3191607
GSK3191607 · 1 trial · 1 indication
AUC(0-t) is the area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration.
AUC(0-infinity) is the area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
RDM is a measure of total radioactivity. Cmax of RDM will be compared with that of the parent drug (GSK3191607).
T1/2 of RDM will be compared with that of the parent drug.
Tmax of RDM will be compared with that of the parent drug.
AUC(0-t) of RDM will be compared with that of the parent drug.
AUC(0-infinity) of RDM will be compared with that of the parent drug.
Subjects will be asked to void their bladders before study treatment administration. A blank urine sample will be collected pre-dose.
| Arm | Type | Description |
|---|---|---|
| [14C]-GSK3191607 IV Microdose | EXPERIMENTAL | Subjects will receive a single microdose of 100 micrograms (mcg) of \[14C\]-GSK3191607 by intravenous infusion over 15 minutes on Day 1 of the study. |
| Name | Type | Description |
|---|---|---|
| [14C]-GSK3191607 | DRUG | \[14C\]-GSK3191607 is a solution to be administered intravenously as a single dose infusion over 15 minutes. It is a radio-labeled product; 100 mcg of \[14C\]-GSK3191607 contains approximately 7.4 kilobecquerel (kBq) of \[14C\] radioactivity. |
Inclusion Criteria: * Between 18 and 55 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ...
GSK3191607 is an investigational small molecule developed by GSK plc for Plasmodium falciparum malaria. It has been studied in a Phase 1 microdose trial in healthy male volunteers in the United Kingdom. The compound remains in clinical development and is not an approved medicine.
GSK3191607 is being evaluated for Plasmodium falciparum malaria, the parasite species responsible for the most severe form of the disease. Its only recorded clinical study enrolled healthy adult volunteers rather than patients with malaria, so the work to date has characterized the drug in healthy subjects.
GSK3191607 is developed by GSK plc, the British pharmaceutical company listed under the ticker GSK. GSK sponsors the clinical program for the compound, including the Phase 1 microdose pharmacokinetic study conducted in the United Kingdom.
GSK3191607 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The compound is investigational and has not been approved by the FDA or any other regulator for the treatment or prevention of malaria.
GSK3191607 has been studied in one completed Phase 1 trial, NCT02737007, titled a microdose study in healthy subjects to describe intravenous pharmacokinetics of GSK3191607. It enrolled 6 healthy male volunteers aged 18 years and older in the United Kingdom and is now completed.
Yes. [14C]-GSK3191607 is an alternative name for GSK3191607, referring to the carbon-14 radiolabeled form used in the microdose pharmacokinetic study. Both names refer to the same investigational small molecule being developed by GSK plc for Plasmodium falciparum malaria.