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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03196557 | A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject | PHASE1 | COMPLETED | 24 | — | — | Mar 31, 2008 | May 5, 2008 | Dec 6, 2019 | 2 | United States |
As measured by flow cytometry
As measured by flow cytometry
As measured by flow cytometry
As measured by flow cytometry
As measured by flow cytometry
As measured by blood concentration
As measured by flow cytometry
Assessed by central labortatory
As measured by the level of the hormone cortisol in the blood
As measured by the level of the hormone in the blood
As measured by blood concentration
As measured by blood concentration
As measured by blood concentration
As measured by blood concentration
As measured by urine concentration
As measured by urine concentration
As measured by urine concentration
As measured by urine concentration
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Specified dose on specified days |
| Arm B | PLACEBO_COMPARATOR | Specified dose on specified days |
| Name | Type | Description |
|---|---|---|
| Prenisolone | DRUG | Specified dose on specified days |
| Placebo | DRUG | Specified dose on dose on specified days |
Inclusion Criteria: * Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive * Signed informed consen...