Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00607906 | First-Time-in-Humans Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of SB756050 | PHASE1 | COMPLETED | 36 | — | — | Nov 16, 2007 | Mar 10, 2008 | Sep 6, 2017 | 1 | United States |
| 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...