Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Raltegravir · 1 trial · 1 indication
| 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 ...
Raltegravir is a small molecule being studied for use in Infection, Human Immunodeficiency Virus. It is currently in Phase 1 clinical development and is being investigated as a potential treatment for this condition.
Raltegravir is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this small molecule for the treatment of Human Immunodeficiency Virus infection.
Raltegravir is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 1 clinical trial has been completed to evaluate its pharmacokinetics.
Raltegravir has one completed clinical trial, NCT01101893, titled "A Drug Interaction Study Evaluating GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects." This Phase 1 study enrolled 15 healthy adult volunteers in the United States.
Raltegravir is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The available data shows one completed Phase 1 trial, but no approval status has been established.