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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00812318 | Healthy Volunteer Study To Assess The Bioavailability of GSK1265744 When Administered Orally Either When Fasted or Following a Meal. | PHASE1 | COMPLETED | 45 | — | — | Jun 1, 2008 | Aug 1, 2008 | Apr 2, 2012 | 1 | United States |
| NCT00659191 | A Healthy Volunteer And Patient Study To Assess The Safety, Tolerability And Pharmacokinetics Of GSK1265744 | PHASE1 | COMPLETED | 58 | — | — | Feb 1, 2008 | Nov 1, 2008 | Oct 15, 2010 | 5 | United States |
Plasma GSK1265744 Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time \[AUC(0-infinity)\], Area under the concentration-time curve over the dosing interval \[AUC(0-t)\], and Maximum observed concentration (Cmax).
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | GSK1265744 10mg oral solution |
| Treatment B | EXPERIMENTAL | GSK1265744 5mg tablet, fasted |
| Treatment C | EXPERIMENTAL | GSK1265744 5mg tablet, fed |
| Name | Type | Description |
|---|---|---|
| GSK1265744 10 mg oral solution | DRUG | GSK1265744 |
| GSK1265744 5 mg tablet | DRUG | GSK1265744 5mg tablet, fasted |
| GSK1265744 | DRUG | - |
Inclusion Criteria: * Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population bein...