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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01031472 | A Study to Assess Relative Bioavailability and Food Effect of New Formulations of GSK2248761 | PHASE1 | COMPLETED | 24 | — | — | Dec 21, 2009 | Mar 11, 2010 | Mar 27, 2020 | 1 | United States |
Plasma samples will be collected for the analysis of AUC (0-inf) of GSK2248761.
Plasma samples will be collected for the analysis AUC (0-tau) of GSK2248761.
Plasma samples will be collected for the analysis of Cmax of GSK2248761.
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Subjects will be randomized in a three way crossover design to either a single dose of GSK2248761 100mg Gelucire capsule administered with food and a single dose of 100mg of formulation 1 or a single dose of 100mg of formulation 3 administered in the fed and fasted state |
| Part B | EXPERIMENTAL | A total of twelve subjects who complete Part A will participate in Part B. Subjects from Part A will be asked to participate on a first come first serve basis until there are 12 subjects, at which time enrolment to Part B will be closed. Part B will be a 2 way cross over study design. Subjects will be randomized to one of a single dose of GSK2248761 100mg Formulation 2 or 4 (based on the evaluation of Part A data) administered with food or in the fasted state. Subjects in Part B will not receive the reference formulation since they previously received this in Part A |
| Name | Type | Description |
|---|---|---|
| GSK2248761 formulation 1 | DRUG | 100mg GSK2248761 formulation 1- fasted 100mg GSK2248761 formulation 1 - with food (moderate fat meal) |
| GSK2248761 reference formulation | DRUG | GSK2248761 100mg Gelucire reference capsule with food |
| GSK2248761 formulation 3 | DRUG | 100mg GSK2248761 formulation 3 fasted 100mg GSK2248761 formulation 3 with food (moderate fat meal) |
| GSK2248761 formulation 2 or 4 | DRUG | 100mg GSK2248761 formulation 2 or 4 - fasted 100mg GSK2248761 formulation 2 or 4 - with food (moderate fat meal) |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ECGs. * Male or female between 18 and 50 years of age inclusive, at the time of signing the infor...