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 being studied in healthy volunteers. It is a formulation of pegvisomant intended for subcutaneous administration. The drug is in Phase 1 clinical development and is not approved for any indication.
1 x/mL pegvisomant is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this pegvisomant formulation.
1 x/mL pegvisomant is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.
1 x/mL pegvisomant was studied in a completed Phase 1 trial, NCT01893866, which evaluated the relative bioavailability, safety, tolerability, and pharmacokinetic comparability of pegvisomant 1 x 30 mg versus 2 x 15 mg subcutaneously administered in healthy subjects. The trial enrolled 17 participants in Belgium.
1 x/mL pegvisomant is a formulation of pegvisomant, a growth hormone receptor antagonist. The drug name refers to a specific concentration and dosing regimen being tested for pharmacokinetic comparability with other pegvisomant doses.