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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03198013 | A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males | PHASE1 | COMPLETED | 120 | — | — | Nov 11, 2008 | May 18, 2009 | Jun 9, 2020 | 1 | Australia |
safety and tolerability
safety and tolerability
| Arm | Type | Description |
|---|---|---|
| Module A | EXPERIMENTAL | Single Ascending Dose |
| Module B | EXPERIMENTAL | Multiple Ascending Dose |
| Name | Type | Description |
|---|---|---|
| Prednisolone | DRUG | Specified dose on specified days |
| BMS-791826 | DRUG | Specified dose on specified days |
| Placebo | DRUG | Specified dose on specified days |
Inclusion Criteria: * Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations * Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive * S...