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Also known as GSK1265744 injectable suspension
GSK1265744 injectable · 1 trial · 1 indication
GSK1265744 pharmacokinetic parameters: area under the plasma concentration time curve from time zero to the last quantifiable time points (AUC(0-tau)), area under the plasma concentration time curve from time zero to infinity (AUC(0-infinity)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), apparent terminal phase half-life for LAP administration (t½), lambda z as a measure of absorption rate constant
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 100 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
| Cohort 2 | EXPERIMENTAL | 200 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
| Cohort 3 | EXPERIMENTAL | 400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
| Cohort 4 | EXPERIMENTAL | 800 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
| Cohort 5 | EXPERIMENTAL | 100 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing |
| Cohort 6 | EXPERIMENTAL | 200 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing |
| Cohort 7 | EXPERIMENTAL | 400 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing |
| Cohort 8 | EXPERIMENTAL | 400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
| Cohort 9 | EXPERIMENTAL | 400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
| Name | Type | Description |
|---|---|---|
| GSK1265744 injectable suspension | DRUG | 200 milligram per milliliter sterile solution for injection |
| Placebo to match injectable suspension | OTHER | placebo |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range ...
GSK1265744 injectable is an investigational long-acting small molecule antiviral developed by GSK plc for infectious disease indications, specifically infections, human immunodeficiency virus and herpesviridae. It is formulated as an injectable suspension and has been studied in a Phase 1 clinical trial in healthy adult subjects.
GSK1265744 injectable is being studied for infections, human immunodeficiency virus and herpesviridae. The only clinical trial to date enrolled healthy volunteers rather than patients, so the asset remains investigational and no approved use has been established for GSK1265744 injectable.
GSK1265744 injectable is developed by GSK plc, which trades under the ticker GSK. The company sponsored the single Phase 1 study of the long-acting injectable suspension that has been completed to date.
GSK1265744 injectable is in Phase 1 development. One Phase 1 trial has been completed and no active trials are ongoing, so the asset is investigational and has not been approved by the FDA for any indication.
GSK1265744 injectable has been evaluated in one completed Phase 1 trial, NCT01756131, titled a single dose escalation study of intramuscular and subcutaneous long-acting GSK1265744 in healthy subjects. It enrolled 72 healthy volunteers aged 18 years and older in a randomized, controlled design.
Yes. GSK1265744 injectable suspension is an alternative name for GSK1265744 injectable. Both refer to the same long-acting injectable formulation of the investigational small molecule developed by GSK plc for infectious disease indications.