Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of Type 2 Diabetes Mellitus. It is a metabolic therapeutic currently in Phase 1 clinical development. The drug is intended to address the needs of patients with this condition, though it remains in early-stage testing and is not yet approved.
SB-756050 immediate release is being developed by GSK plc, a global pharmaceutical company traded under the ticker GSK. The company is conducting clinical trials to evaluate the safety, pharmacokinetics, and pharmacodynamics of this investigational drug in patients with Type 2 Diabetes Mellitus.
SB-756050 immediate release is in Phase 1 clinical development. A first-time-in-humans study has been completed to assess its safety, pharmacokinetics, and pharmacodynamics. The drug is investigational and has not been approved by regulatory authorities. It remains in early-stage testing for Type 2 Diabetes Mellitus.
SB-756050 immediate release has one completed clinical trial, NCT00607906, titled 'First-Time-in-Humans Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of SB756050.' This Phase 1 study enrolled 36 participants in the United States and included healthy volunteers. The trial was controlled and randomized, though not double-blinded.
SB-756050 immediate release is a formulation of the investigational drug SB-756050. The 'immediate release' designation refers to the drug's release profile, which allows for rapid absorption after administration. This formulation is being studied in clinical trials for the treatment of Type 2 Diabetes Mellitus.