Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2140944 Drug single dose of, and dose to be determined · 1 trial · 1 indication
Measurements include area under the plasma concentration curve (AUC) from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity), AUC over the dosing interval AUC(0-tau). AUC (0-12) and AUC(0-24).
Measurements include maximum observed concentration (Cmax), systemic clearance of parent drug (CL). volume of distribution at steady state of parent drug after intravascular administration (Vdss), Mean residence time (MRT) and terminal phase half-life (t1/2)
Measurements include AUC from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity), AUC over the dosing interval AUC(0-tau). AUC (0-8), AUC (0-12) and AUC(0-24).
Measurements include Cmax, CL. Vdss, MRT and t1/2.
Measurements include AUC(0-tau). Cmax, pre-dose (trough) concentration at the end of the dosing interval (Cτ), accumulation ratio (Ro) and CL
| Arm | Type | Description |
|---|---|---|
| Cohort A1 | EXPERIMENTAL | GSK2140944 200mg single dose |
| Cohort A2 | EXPERIMENTAL | GSK2140944 600mg single dose |
| Cohort A3 | EXPERIMENTAL | GSK2140944 1200mg single dose |
| Cohort A4 | EXPERIMENTAL | GSK2140944 1800mg single dose |
| Cohort A5 | EXPERIMENTAL | GSK2140944 1800mg single dose |
| Cohort A6 | EXPERIMENTAL | GSK2140944 dose to be determined, single dose |
| Cohort B1 | EXPERIMENTAL | GSK2140944 400 mg repeat dose BID up to 7 days |
| Cohort B2 | EXPERIMENTAL | GSK2140944 750 mg repeat dose BID up to 7 days |
| Cohort B3 | EXPERIMENTAL | GSK2140944 1000 mg repeat dose BID up to 7 days |
| Cohort B4 | EXPERIMENTAL | GSK2140944 to be determined repeat dose BID up to 7 days |
| Cohort B5 | EXPERIMENTAL | GSK2140944 to be determined repeat dose TID up to 14 days |
| Cohort B6 | EXPERIMENTAL | GSK2140944 to be determined repeat dose TID up to 14 days |
| Name | Type | Description |
|---|---|---|
| Part A: GSK2140944 Drug single dose of 200mg, 600mg, 1200mg, 1800 mg, and dose to be determined | DRUG | Subjects receive a single dose of GSK2140944 |
| Part B: GSK2140944 Repeat Drug dose of 400mg, 750mg, 1000 mg, and dose to be determined | DRUG | Subjects will receive repeat doses of GSK2140944 BID/TID for up to 14 Days |
Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin less than and equal to 1.5xULN (isolated bilirubin less than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%). * Healthy as determined by a responsible and experienced physician, based on a medi...
GSK2140944 is an investigational small-molecule drug being studied for infections, specifically respiratory tract infections. It is in Phase 1 clinical development and has not been approved for any use. The only completed trial evaluated its safety, tolerability, and pharmacokinetics in healthy adult volunteers.
GSK2140944 is being developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 trial of the drug. No partnership or licensing arrangement for this asset is disclosed.
GSK2140944 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.
GSK2140944 has been studied in one completed Phase 1 trial, NCT01615796, titled Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Repeat IV Doses. The trial enrolled 86 healthy adult volunteers in Australia and was randomized and controlled.