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 developed for Type 2 Diabetes Mellitus. It has been studied in early-stage clinical trials in overweight subjects and in drug interaction studies. The drug is not approved and remains in clinical development.
GSK376501 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company has sponsored multiple Phase 1 clinical trials of the drug in the United States.
GSK376501 is in Phase 1 clinical development. All completed trials for the drug are Phase 1 studies. It is an investigational drug and has not been approved by regulatory authorities.
GSK376501 has been studied in four completed Phase 1 trials, including NCT00404963 and NCT00495014, which investigated safety and metabolism in overweight subjects, NCT00605449, a drug interaction study with simvastatin, and NCT00615212, a study of its effect on CYP450 activity.
GSK376501 is the primary name used in clinical trial registrations. No alternative names have been reported in the available trial information. The drug is identified solely as GSK376501 in the studies it has been tested in.