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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01163851 | Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin | PHASE1 | COMPLETED | 25 | — | — | Jul 1, 2010 | Apr 1, 2011 | Mar 1, 2018 | 5 | United States |
Plasma decay half-life is the time measured for the plasma concentration of PF-04950615 to decrease by one half.
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 12 hours.
Plasma decay half-life is the time measured for the plasma concentration of atorvastatin to decrease by one half.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
| Arm | Type | Description |
|---|---|---|
| PF-04950615 (RN316) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 4 mg/kg | BIOLOGICAL | RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes. |
| 0.5 mg/kg | BIOLOGICAL | RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes. |
Inclusion Criteria: * On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1. * BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg. Exclusion Criteria: * History of a cardiovascular event (e.g., MI ) during the past year. * Poorly controlled Type 1 or Typ...