Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
1 x/mL pegvisomant · 1 trial · 1 indication
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 ...
1 x/mL pegvisomant is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 clinical trial in healthy volunteers, and the specific therapeutic indication for this formulation has not been disclosed. It is a pegvisomant formulation rather than an approved commercial product.
1 x/mL pegvisomant is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 clinical trial of this pegvisomant formulation. The drug remains an investigational asset in Pfizer's pipeline rather than a marketed product.
1 x/mL pegvisomant is in Phase 1 development. Its only recorded trial, NCT01893866, was a Phase 1 study that has been completed. The program enrolled 17 participants and has no active trials at this time. It is an investigational drug and is not an approved therapy.
1 x/mL pegvisomant has been studied in one clinical trial, NCT01893866, titled a relative bioavailability study evaluating safety, tolerability, and pharmacokinetic comparability of pegvisomant 1 x 30 mg versus 2 x 15 mg administered subcutaneously in healthy subjects. The Phase 1 trial was completed, enrolled 17 healthy volunteers in Belgium, and was controlled and randomized.
The Phase 1 trial NCT01893866 evaluated the relative bioavailability, safety, tolerability, and pharmacokinetic comparability of pegvisomant 1 x 30 mg versus 2 x 15 mg given subcutaneously in healthy subjects. It enrolled 17 participants in Belgium, used a controlled and randomized design, and has been completed.