Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK1265744 Na Salt · 1 trial · 1 indication
Plasma GSK1265744 PK parameters: area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time AUC(0-infinity); AUC from time zero to time t, AUC(0-t), and maximum observed concentration, Cmax.
| Arm | Type | Description |
|---|---|---|
| GSK1265744 Na Salt Tablets | EXPERIMENTAL | Subjects will receive single dose of GSK1265744 sodium salt (30 mg) tablet on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 milliliter (mL) of water. |
| GSK1265744 Free Acid Nanomilled Capsules | EXPERIMENTAL | Subjects will receive single dose of GSK1265744 free acid nanomilled (30 mg) capsule on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 mL of water. |
| GSK1265744 Free Acid Micronized Capsules | EXPERIMENTAL | Subjects will receive single dose of GSK1265744 free acid micronized (30 mg) capsule on Day 1 of the respective period per randomized sequence, orally in fasted condition, with 240 mL of water. |
| Name | Type | Description |
|---|---|---|
| GSK1265744 Na Salt Tablets | DRUG | Each tablet contains 30 mg of GSK1265744 sodium salt and excipients. |
| GSK1265744 Free Acid Nanomilled Capsules | DRUG | Each capsule contains 30 mg of nanomilled and spray dried GSK1265744 free acid, blended with excipients. |
| GSK1265744 Free Acid Micronized Capsules | DRUG | Each capsule contains 30 mg of micronized GSK1265744 free acid, blended with excipients. |
Inclusion Criteria: * Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin =\< 1.5x upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician, bas...
GSK1265744 Na Salt is an investigational small molecule being developed for infections, specifically Human Immunodeficiency Virus (HIV) and Hepatitis. It is currently in Phase 1 clinical development, meaning it is still being studied and is not yet approved for any use.
GSK1265744 Na Salt is being developed by GSK plc, a global biopharmaceutical company. GSK plc is listed on the stock exchange under the ticker symbol GSK. The drug is currently in Phase 1 clinical trials for infectious diseases.
GSK1265744 Na Salt is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of infections, including Human Immunodeficiency Virus (HIV) and Hepatitis.
GSK1265744 Na Salt has one completed clinical trial, NCT01648257, titled "Relative Bioavailability Study of GSK1265744 Formulations." This Phase 1 study enrolled 18 participants in the United States and included healthy volunteers. The trial was controlled but not double-blinded.
GSK1265744 Na Salt is a sodium salt form of GSK1265744. The clinical trial NCT01648257 specifically studied GSK1265744 formulations, indicating that the salt form is being evaluated for its relative bioavailability compared to other formulations of the same active compound.