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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01101893 | A Drug Interaction Study Evaluating GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects | PHASE1 | COMPLETED | 15 | — | — | Apr 1, 2010 | Jun 1, 2010 | Sep 11, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Period 1 | EXPERIMENTAL | In period 1 all subjects will receive Raltegravir 400mg q12h from Day 1 to Day 5 |
| Period 2 | EXPERIMENTAL | In period 2 all subjects will receive GSK2248761 200mg q24h from Day 1 to Day 5. |
| Period 3 | EXPERIMENTAL | Day 1 of Period 3 will be the day after Day 5 of Period 2. Subjects will receive GSK2248761 200mg q24h + raltegravir 400mg q12h from Day 1 to Day 5. |
| Name | Type | Description |
|---|---|---|
| Raltegravir | DRUG | raltegravir 400mg q12h x 5 days (Reference Treatment) |
| GSK2248761 | DRUG | GSK2248761 200mg q24h x 5 days (Reference Treatment) |
| GSK2248761 + Raltegravir | DRUG | GSK2248761 200mg q24h + raltegravir 400mg q12h x 5 days (Test Treatment) |
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 ...