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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00759564 | A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function | PHASE1 | COMPLETED | 29 | — | — | Nov 1, 2008 | Mar 1, 2010 | Mar 11, 2016 | 2 | United States, Belgium |
PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.
Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).
AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).
PF-03709270 is an oral prodrug of CP-70,429. Upon oral absorption, PF-03709270 is rapidly hydrolyzed, yielding the active drug CP-70,429. Cmax of CP-70429 following CP-70,429 intravenous dose was reported.
Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).
AUC (0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).
| Arm | Type | Description |
|---|---|---|
| IV CP-70,429 and cross over to PF-03709270 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CP-70,429 and PF-03709270 | DRUG | Study Periods 1 and 2 will be separated by a minimum of 14 days. In Period 1, subjects will receive a single dose of CP-70429 (800 mg given as a 1.5 hour intravenous infusion), while in Period 2, subjects will receive a single oral dose of PF-03709270 (1000 mg). |
Inclusion Criteria: Subjects must meet one of the following renal function categories: * Normal renal function (CLcr \>80 mL/min). * Mild renal impairment (CLcr \>50 and \<80 mL/min). * Moderate renal impairment (CLcr \>30 and \<50 mL/min). * Severe renal impairment (CLcr \<30 mL/min). Exclusion ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tozorakimab |
| GSK plc Sponsored ADR | GSK | 3 | PHASE1 | Pn-MAPS30plus, PCV20 |
| Pfizer Inc. | PFE | 4 | — | Receipt of PCV20 |
| Sanofi SA Sponsored ADR | SNY | 1 | — | Undisclosed |
| Gilead Sciences, Inc. | GILD | 1 | — | Undisclosed |
| Grace Therapeutics, Inc. | GRCE | 1 | NA | Undisclosed |
| Co-Diagnostics, Inc. | CODX | 1 | — | Undisclosed |