Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01648257 | Relative Bioavailability Study of GSK1265744 Formulations | PHASE1 | COMPLETED | 18 | — | — | Aug 1, 2012 | Nov 1, 2012 | Aug 12, 2016 | 1 | United States |
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...