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Also known as SB-756050 immediate release capsule
SB-756050 immediate release · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Subjects receiving treatment in cohort A1 | EXPERIMENTAL | Eligible subjects will receive oral immediate release capsules of SB-756050 with doses of 5 milligrams, 15 milligrams, 50 milligrams, or 100 milligrams. |
| Subjects receiving treatment in cohort A2 | EXPERIMENTAL | Eligible subjects will receive oral immediate release capsules of SB-756050 with doses of 100 milligrams, 200 milligrams, 300 milligrams, or 400 milligrams. |
| Subjects receiving treatment in cohort A3 | EXPERIMENTAL | Eligible subjects will receive oral immediate release capsules of SB-756050 with a dose of 150 milligrams. Subjects will also receive oral modified release capsules of SB-756050 with doses of 150 milligrams, 300 milligrams, or 400 milligrams. |
| Subjects receiving treatment in cohort A4 | EXPERIMENTAL | Eligible subjects will receive SB-756050 in this additional cohort. |
| Subjects receiving treatment in cohort B1 | EXPERIMENTAL | Eligible subjects will receive oral modified release capsules of SB-756050 with doses of 50 milligrams, 150 milligrams or 400 milligrams. Subjects will also receive immediate release oral capsules of SB-756050 with a dose of 150 milligrams. |
| Name | Type | Description |
|---|---|---|
| SB-756050 immediate release capsule | DRUG | SB-756050 immediate release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white drug layered pellets. Each capsule will contain 5, 25 or 100 milligrams of SB-756050. |
| SB-756050 modified release capsule | DRUG | SB-756050 modified release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white enteric coated drug layered pellets. Each capsule will contain either 25or 100 milligrams of SB-756050. |
| Placebo | DRUG | Subjects will also receive placebo capsules. |
Inclusion Criteria: Healthy Subjects * Healthy male or female subject as determined by a responsible physician, based on a medical evaluation including history, physical examination, vitals signs, laboratory tests, and cardiac monitoring. * Female subjects must be of non-childbearing potential inc...
SB-756050 immediate release is an investigational small molecule developed by GSK plc for type 2 diabetes mellitus. It is an immediate release capsule formulation that has been studied in a first-time-in-humans Phase 1 clinical trial. It is not an approved medicine and remains in clinical development.
SB-756050 immediate release was studied for the treatment of type 2 diabetes mellitus. Its only recorded clinical trial enrolled healthy adult volunteers rather than patients with diabetes, and it was designed to assess safety, pharmacokinetics and pharmacodynamics. The drug is investigational and has no approved use.
SB-756050 immediate release is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the first-time-in-humans Phase 1 study of the immediate release capsule formulation in type 2 diabetes.
SB-756050 immediate release is in Phase 1 development. One Phase 1 trial has been completed and no trials are currently active. The drug is investigational and has not been approved by the FDA or any other regulator for the treatment of type 2 diabetes.
SB-756050 immediate release has been evaluated in one completed Phase 1 trial, NCT00607906, titled a first-time-in-humans study to assess safety, pharmacokinetics and pharmacodynamics of SB756050. The trial enrolled 36 healthy adult volunteers in the United States, was randomized and controlled, and included both male and female participants aged 18 years and older.
Yes. SB-756050 immediate release capsule is another name for SB-756050 immediate release. Both refer to the same GSK small molecule formulation studied in the Phase 1 first-time-in-humans trial NCT00607906 for type 2 diabetes mellitus.