Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of malaria, specifically falciparum malaria. It is currently in Phase 1 clinical development, meaning it is still being tested in early-stage trials to evaluate its safety and pharmacokinetics in humans.
GSK3191607 is being developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded under the ticker symbol GSK on major stock exchanges.
GSK3191607 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing early-stage clinical trials to assess its safety and how it behaves in the body.
GSK3191607 has one completed Phase 1 clinical trial, identified as NCT02737007. This study was a microdose trial in healthy male subjects to describe the intravenous pharmacokinetics of GSK3191607. The trial enrolled 6 participants and was conducted in the United Kingdom.
GSK3191607 is a distinct investigational small molecule being developed for falciparum malaria. It is not known to be the same as any other marketed drug, and its mechanism of action has not been publicly disclosed in available clinical trial information.