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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01893866 | A Relative Bioavailability Study To Evaluate Safety, Tolerability And Pharmacokinetic Comparability Of Pegvisomant 1 X 30 Mg Vs 2 X 15 Mg Subcutaneously Administered In Healthy Subjects | PHASE1 | COMPLETED | 17 | — | — | Aug 1, 2013 | Oct 1, 2013 | Dec 12, 2013 | 1 | Belgium |
Area under the concentration-time profile from time zero extrapolated to infinite time
Area under the concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 1 x 30 mg/mL pegvisomant | DRUG | Subcutaneous injection, 30 mg, single dose. |
| 2 x 15 mg/mL pegvisomant | DRUG | Subcutaneous injection, 2 injections of 15 mg, single dose. |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG ...