Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 a small molecule in clinical development for infections, including Human Immunodeficiency Virus and Herpesviridae. It is being studied as a long-acting injectable formulation. The drug is currently in Phase 1 clinical development and is not approved for any indication.
GSK1265744 injectable is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this long-acting injectable small molecule for infectious disease indications.
GSK1265744 injectable is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities, and its safety and efficacy are still being evaluated in clinical studies.
GSK1265744 injectable has one completed clinical trial, NCT01756131, which was a single dose escalation study in healthy subjects. The trial investigated the safety, tolerability, and pharmacokinetics of intramuscular and subcutaneous long-acting GSK1265744. The study enrolled 72 participants and was controlled but not double-blinded.
GSK1265744 injectable is being studied as a long-acting formulation for intramuscular and subcutaneous administration. The completed Phase 1 trial evaluated both routes of administration in healthy volunteers to assess the drug's safety, tolerability, and pharmacokinetic profile.