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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01209117 | A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435 | PHASE1 | COMPLETED | 24 | — | — | Sep 1, 2010 | Jan 1, 2011 | Jun 8, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Periods 1 - 4 | EXPERIMENTAL | Subjects will be randomized in a cross over fashion to receive the GSK2248761 WBM capsule formulation or one of three WBM tablet formulations in one of four sequences. |
| Period 5 | EXPERIMENTAL | Subjects in Part B will receive a formulation of GSK2248761 200mg WBM Tablet chosen from Periods 1 - 4 in part A in the fed state (moderate fat meal). |
| Name | Type | Description |
|---|---|---|
| GSK2248761 WBM Capsule | DRUG | 200 mg GSK2248761 WBM capsule (reference) 2 X100mg |
| GSK2248761 WBM Tablet Formulation 1 | DRUG | GSK2248761 WBM Tablet 200mg manufacturing process 1 |
| GSK2248761 WBM Tablet Formulation 2 | DRUG | GSK2248761 WBM Tablet 200mg manufacturing process 2 |
| GSK2248761 WBM Tablet Formulation 3 | DRUG | GSK2248761 WBM Tablet 200mg manufacturing process 3 |
| GSK2248761 WBM Tablet | DRUG | GSK2248761 WBM tablet 200mg manufacturing process 1, 2, or 3 chosen from Period 1 - 4 |
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. A subject with a clinical abnormality or laboratory parameters outside the reference range ...