Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK1322322 containing radioactive 14C-GSK1322322 · 1 trial · 1 indication
Plasma PK parameters will be statistically summarized by treatment. Plasma concentration-time data will be analyzed by non-compartmental methods. Following PK parameters will be studied: Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time \[AUC(0-infinity)\], AUC(0-t), maximum observed concentration (Cmax), time of occurrence of Cmax (tmax), terminal phase half-life (t1/2) for IV and oral solution regimens and systemic clearance (CL) and volume of distribution (Vss) for IV regimen only.
Total recovery of radioactivity in urine and feces (as a percentage of total radioactive dose in each interval and cumulative)
| Arm | Type | Description |
|---|---|---|
| GSK1322322 1000 mg IV | EXPERIMENTAL | On Day 1 of Period 1, after an overnight fast, subjects will receive GSK1322322 1000 mg IV single dose (containing approximately 45.5 microcurie \[μCi\] radioactive 14C-GSK1322322) for intravenous infusion over 60 minutes. |
| GSK1322322 1200 mg Oral Solution | EXPERIMENTAL | On Day 1 of Period 2, after an overnight fast, subjects will receive GSK1322322 1200 mg oral solution single dose (containing approximately 54.5 μCi radioactive 14C-GSK1322322). |
| Name | Type | Description |
|---|---|---|
| GSK1322322 1000 mg containing radioactive 14C-GSK1322322 | DRUG | GSK1322322 1000 mg is a mesylate salt powder for injection containing 45.5 μCi radioactive 14C-GSK1322322 1000 mg as free base. |
| GSK1322322 1200 mg containing radioactive 14C-GSK1322322 | DRUG | GSK1322322 1200 mg is a mesylate salt powder for oral solution containing 54.5 μCi radioactive 14C-GSK1322322 1200 mg as free base. |
Inclusion Criteria: * Healthy male subjects between 30 and 55 years of age, with body weight between 60 to 80 kilograms (kg) and a history of regular bowel movements * Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods from first dose of...
GSK1322322 is an investigational antibacterial small molecule being studied for the treatment of bacterial infections. It was evaluated in a Phase 1 clinical study that administered the drug to healthy adult male volunteers to characterize its pharmacokinetics and excretion. It is not an approved therapy.
GSK1322322 is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. The company sponsored the clinical study of the compound, which was conducted in the United States.
GSK1322322 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The completed study enrolled 5 healthy male volunteers aged 30 years and older and was controlled in design.
GSK1322322 has been studied in clinical trial NCT01663389, titled A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1322322 After an Intravenous and an Oral Dose. The Phase 1 trial was completed in the United States with 5 enrolled healthy male volunteers.
Yes. GSK1322322 1000 mg containing radioactive 14C-GSK1322322 is an alternative name for GSK1322322. The 14C label is a carbon-14 radiotracer used in the Phase 1 study to track how the drug is absorbed, distributed, and excreted after intravenous and oral dosing.