Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK376501 · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Subjects receiving midazolam | ACTIVE_COMPARATOR | Eligible subjects will receive midazolam oral syrup with a dose of 5 milligrams on Day 1. |
| Subjects receiving rosiglitazone | ACTIVE_COMPARATOR | Eligible subjects will receive rosiglitazone oral tablet with a dose of 4 milligrams on Day 2. |
| Subjects receiving flurbiprofen | ACTIVE_COMPARATOR | Eligible subjects will receive flurbiprofen oral tablet with a dose of 50 milligrams on Day |
| Subjects receiving GSK376501 | EXPERIMENTAL | Eligible subjects will receive GSK376501 oral tablet with a dose of 75 milligrams from Day 4 to Day 10. |
| Subjects receiving GSK376501+ midazolam | EXPERIMENTAL | Eligible subjects will receive GSK376501 oral tablet with a dose of 75 milligrams along with midazolam oral tablet of 5 milligrams on Day 11. |
| Subjects receiving GSK376501 + rosiglitazone | EXPERIMENTAL | Eligible subjects will receive GSK376501 oral tablet with a dose of 75 milligrams along with rosiglitazone oarl tablet of 4 milligrams on Day 12. |
| Subjects receiving GSK376501 + flurbiprofen | EXPERIMENTAL | Eligible subjects will receive GSK376501 oral tablet with a dose of 75 milligrams along with flurbiprofen oral tablet of 50 milligrams on Day 13. |
| Name | Type | Description |
|---|---|---|
| GSK376501 | DRUG | GSK376501 oral tablet will be available with dosing strengths of 75 milligrams administered once daily. Biconvex, It will be a round, white film-coated tablets with both plain sides and no identifying markings. |
| Midazolam | DRUG | Midazolam oral syrup will be available with a dose of 5 milligrams administered once daily. It will be a clear, red to purplish-red, cherry-flavored syrup. |
| Rosiglitazone | DRUG | Rosiglitazone oral tablet will be available with dosing strengths of 4 milligrams administered once daily. It will be a orange colored tablet debossed with SB on one side and 4 on the other. |
| Flurbiprofen | DRUG | Rosiglitazone oral tablet will be available with dosing strengths of 50 milligrams administered once daily. It will be a blue, oval, film coated tablet. |
| Placebo | DRUG | - |
Inclusion Criteria: * Healthy as determined by a qualified physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population...
GSK376501 is an investigational small molecule being studied for Type 2 Diabetes Mellitus. It is a metabolic candidate developed by GSK plc. All four of its clinical trials have been completed, and the program remains in Phase 1 clinical development.
GSK376501 is developed by GSK plc, which trades under the ticker GSK. The company sponsored all four Phase 1 trials of the compound, which were conducted in the United States in participants with Type 2 Diabetes Mellitus or in healthy volunteers.
GSK376501 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved for any indication. Four Phase 1 trials have been completed, with no active trials currently listed, and total enrollment across those studies was 204 participants.
GSK376501 has been evaluated in four completed Phase 1 trials: NCT00615212, which studied its effect on CYP450 activity; NCT00605449, a drug interaction study with simvastatin; NCT00495014; and NCT00404963, both of which investigated safety and metabolism in overweight subjects.
Across the four completed Phase 1 trials, 204 participants were enrolled. Enrollment by study was 23 in NCT00615212, 39 in NCT00605449, 70 in NCT00495014, and 72 in NCT00404963. The studies were randomized and used an active-controlled design.