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CP-70, 429 and PF-03709270

Phase 1

Pneumonia | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Mar 11, 2016

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

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Clinical trial landscape

CP-70, 429 and PF-03709270 · 1 trial · 1 indication

Phase 1 1
NCT00759564A 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 FunctionPneumonia
COMPLETED29 Analytics
PHASE1COMPLETED
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
PneumoniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following CP-70,429 Intravenous Dose
0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)

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.

Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following CP-70,429 Intravenous Dose
0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following CP-70,429 Intravenous Dose
0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)

Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70,429 Following CP-70,429 Intravenous Dose
0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)

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 (CLr) of CP-70429 Following CP-70,429 Intravenous Dose
0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose

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).

Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following PF-03709270 Oral Dose
0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)

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.

Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following PF-03709270 Oral Dose
0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following PF-03709270 Oral Dose
0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)

Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70429 Following PF-03709270 Oral Dose
0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)

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 (CLr) of CP-70429 Following PF-03709270 Oral Dose
0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose

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).

Secondary Endpoints

Terminal Elimination Half Life (t1/2) of CP-70429 Following CP-70,429 Intravenous Dose
0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)
Terminal Elimination Half Life (t1/2) of CP-70429 Following PF-03709270 Oral Dose
0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)
Clearance (CL)
0 (pre-dose), 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
IV CP-70,429 and cross over to PF-03709270EXPERIMENTAL -

Interventions

NameTypeDescription
CP-70,429 and PF-03709270DRUGStudy 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).
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersYes
Study Sites2

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 ...

Countries:United StatesBelgium
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Frequently asked questions about CP-70, 429 and PF-03709270

What is CP-70,429 and PF-03709270 used for?

CP-70,429 and PF-03709270 is an investigational small molecule being developed by Pfizer for the treatment of pneumonia. It is currently in Phase 1 clinical development, meaning it is still being studied and has not been approved for use.

Who makes CP-70,429 and PF-03709270?

CP-70,429 and PF-03709270 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is in Phase 1 clinical development for pneumonia.

What phase is CP-70,429 and PF-03709270 in?

CP-70,429 and PF-03709270 is in Phase 1 clinical development. It is an investigational drug for pneumonia and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial.

What clinical trials is CP-70,429 and PF-03709270 in?

CP-70,429 and PF-03709270 has been studied in one completed Phase 1 clinical trial, identified as NCT00759564. This trial investigated the pharmacokinetics, safety, and tolerability of intravenous and oral forms of the compound in subjects with varying degrees of renal impairment and normal renal function.

Is CP-70,429 the same as PF-03709270?

Yes, CP-70,429 and PF-03709270 refer to the same investigational drug. The compound is being developed by Pfizer for the treatment of pneumonia and is currently in Phase 1 clinical development.