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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01098513 | GSK1349572 Relative Bioavailability Study | PHASE1 | COMPLETED | 24 | — | — | Apr 1, 2010 | Jul 1, 2010 | Jun 9, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Subjects will be randomized in a three-way crossover design to receive a single dose of each of three different tablet formulations of GSK1349572 50 mg (2 tablets). Formulation AP, AW and AX. |
| Part B | EXPERIMENTAL | A total of 18 subjects who complete Part A will return for Part B. Subjects from Part A will be asked to participate on a first come first served basis until there are 18 subjects, at which time enrolment to Part B will be closed. Part B will be a three way crossover design using either formulation AW or AX depending upon the results from Part A. Subjects will receive a single dose of 50 mg GSK1349572 with either a low fat, moderate fat or high fat meal in each period. |
| Name | Type | Description |
|---|---|---|
| GSK1349572 formulation AP | DRUG | GSK1349572 50 mg single dose fasted. |
| GSK1349572 formulation AW | DRUG | GSK1349572 formulation AW 50 mg single dose in Part A and 75 to 200 mg fasted or with moderate or high fat meal in Part B. |
| GSK1349572 formulation AX | DRUG | GSK1349572 formulation AX 50 mg in Part A and 75-200 mg fasted or with a moderate or high fat meal in Part B |
Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin less than or equla to 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician, based on a medical evaluation in...