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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

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ClinicalTrials.gov Identifier: NCT00759564
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : January 18, 2016
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Pneumonia
Intervention Drug: CP-70,429 and PF-03709270
Enrollment 29
Recruitment Details This was a fixed sequence design study (not a complete 2 way crossover) in parallel groups of participants with varying degrees of renal impairment, where all subjects received the intravenous formulation in first period and then received the oral formulation in second period.
Pre-assignment Details Participants were planned to receive CP-70,429 800 milligram (mg) in all reporting groups. For severe renal impairment group, CP-70,429 dose was decreased from 800 mg to 200 mg as per protocol amendment. Only 1 participant received 800 mg dose and was excluded from all descriptive and statistical analyses as per change in planned analysis.
Arm/Group Title CP-70,429 (800 mg) + PF-03709270: Normal Renal Function CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment CP-70,429 (200 mg) + PF-03709270: Severe Renal Impairment
Hide Arm/Group Description Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP­-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-­70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF­-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period.
Period Title: First Intervention Period (4 Days)
Started 8 8 8 1 4
Completed 8 8 8 1 4
Not Completed 0 0 0 0 0
Period Title: Washout Period (at Least 14 Days)
Started 8 8 8 1 4
Completed 8 8 8 1 3
Not Completed 0 0 0 0 1
Reason Not Completed
Adverse Event             0             0             0             0             1
Period Title: Second Intervention Period (4 Days)
Started 8 8 8 1 3
Completed 8 8 8 1 3
Not Completed 0 0 0 0 0
Arm/Group Title CP-70,429 (800 mg) + PF-03709270: Normal Renal Impairment CP-70,429 (800 mg) + PF-03709270: Mild Renal Impairment CP-70,429 (800 mg) + PF-03709270: Moderate Renal Impairment CP-70,429 (800 mg) + PF-03709270: Severe Renal Impairment CP-70,429 (200 mg) + PF-03709270: Severe Renal Function Total
Hide Arm/Group Description Participants with normal renal function (defined by creatinine clearance [CLcr] greater than [>] 80 milliliter per minute [mL/min]) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants with mild renal impairment (defined by CLcr >50 and less than or equal to [<=] 80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants with moderate renal impairment (defined by CLcr greater than or equal to >=30 and <=50 mL/min) received a single dose of CP­-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-­70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period followed by a single oral dose of PF­-03709270 1000 mg in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 1 4 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 1 participants 4 participants 29 participants
60.4  (3.2) 60.6  (7.3) 64.3  (15.7) 55 [1]   (NA) 69  (9.4) 62.5  (9.9)
[1]
Standard deviation was not calculated as single participant was analyzed.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 1 participants 4 participants 29 participants
Female
3
  37.5%
3
  37.5%
2
  25.0%
0
   0.0%
4
 100.0%
12
  41.4%
Male
5
  62.5%
5
  62.5%
6
  75.0%
1
 100.0%
0
   0.0%
17
  58.6%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following CP-70,429 Intravenous Dose
Hide Description 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 Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
17700  (1880.3) 22070  (3420.8) 28940  (6880.0) 10340  (2784.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-70,429 (800 mg): Normal Renal Function, CP-70,429 (800 mg): Mild Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 124.71
Confidence Interval (2-Sided) 90%
106.57 to 145.94
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-70,429 (800 mg): Normal Renal Function, CP-70,429 (800 mg): Moderate Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 163.51
Confidence Interval (2-Sided) 90%
139.72 to 191.34
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CP-70,429 (800 mg): Normal Renal Function, CP-70,429 (200 mg): Severe Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 58.40
Confidence Interval (2-Sided) 90%
48.16 to 70.83
Estimation Comments [Not Specified]
2.Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following CP-70,429 Intravenous Dose
Hide Description [Not Specified]
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Median (Full Range)
Unit of Measure: hours
1.00
(1.00 to 1.50)
1.50
(1.00 to 1.50)
1.50
(1.50 to 1.50)
1.50
(1.00 to 1.50)
3.Primary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following CP-70,429 Intravenous Dose
Hide Description Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter (ng*hr/mL)
31990  (4793.3) 53610  (10520) 78940  (23937) 34270  (8430.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-70,429 (800 mg): Normal Renal Function, CP-70,429 (800 mg): Mild Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 167.59
Confidence Interval (2-Sided) 90%
137.27 to 204.61
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-70,429 (800 mg): Normal Renal Function, CP-70,429 (800 mg): Moderate Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 246.76
Confidence Interval (2-Sided) 90%
202.11 to 301.27
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CP-70,429 (800 mg): Normal Renal Function, CP-70,429 (200 mg): Severe Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 107.13
Confidence Interval (2-Sided) 90%
88.06 to 130.32
Estimation Comments [Not Specified]
4.Primary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70,429 Following CP-70,429 Intravenous Dose
Hide Description 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).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
32160  (4775.5) 54070  (10647) 79870  (24619) 35410  (9610.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-70,429 (800 mg): Normal Renal Function, CP-70,429 (800 mg): Mild Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 168.14
Confidence Interval (2-Sided) 90%
137.40 to 205.75
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-70,429 (800 mg): Normal Renal Function, CP-70,429 (800 mg): Moderate Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 248.38
Confidence Interval (2-Sided) 90%
202.98 to 303.94
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CP-70,429 (800 mg): Normal Renal Function, CP-70,429 (200 mg): Severe Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 110.12
Confidence Interval (2-Sided) 90%
89.84 to 134.98
Estimation Comments [Not Specified]
5.Primary Outcome
Title Renal Clearance (CLr) of CP-70429 Following CP-70,429 Intravenous Dose
Hide Description 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).
Time Frame 0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Geometric Mean (Standard Deviation)
Unit of Measure: liter per hour (L/hr)
8.035  (5.578) 6.936  (2.516) 3.043  (3.297) 2.303  (0.605)
6.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of CP-70429 Following PF-03709270 Oral Dose
Hide Description 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 Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title PF-­03709270 (1000 mg): Normal Renal Function PF-­03709270 (1000 mg): Mild Renal Impairment PF-­03709270 (1000 mg): Moderate Renal Impairment PF-­03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
2747  (420.58) 3704  (1053.3) 6215  (1841.3) 7830  (738.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-­03709270 (1000 mg): Normal Renal Function, PF-­03709270 (1000 mg): Mild Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 134.86
Confidence Interval (2-Sided) 90%
109.88 to 165.52
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-­03709270 (1000 mg): Normal Renal Function, PF-­03709270 (1000 mg): Moderate Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 226.28
Confidence Interval (2-Sided) 90%
184.36 to 277.72
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-­03709270 (1000 mg): Normal Renal Function, PF-­03709270 (1000 mg): Severe Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 285.05
Confidence Interval (2-Sided) 90%
221.80 to 366.33
Estimation Comments [Not Specified]
7.Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-70429 Following PF-03709270 Oral Dose
Hide Description [Not Specified]
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title PF-­03709270 (1000 mg): Normal Renal Function PF­-03709270 (1000 mg): Mild Renal Impairment PF-­03709270 (1000 mg): Moderate Renal Impairment PF­-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Median (Full Range)
Unit of Measure: hours
1.50
(0.50 to 2.00)
2.50
(1.00 to 4.00)
1.50
(1.00 to 3.00)
2.50
(1.50 to 4.00)
8.Primary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-70429 Following PF-03709270 Oral Dose
Hide Description Area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration (AUClast).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title PF­03709270 (1000 mg): Normal Renal Function PF­-03709270 (1000 mg): Mild Renal Impairment PF-­03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF­03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
6403  (1355.9) 13400  (4948.8) 22600  (9034.3) 47560  (15782)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF­03709270 (1000 mg): Normal Renal Function, PF­-03709270 (1000 mg): Mild Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 209.31
Confidence Interval (2-Sided) 90%
158.81 to 275.87
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF­03709270 (1000 mg): Normal Renal Function, PF-­03709270 (1000 mg): Moderate Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 353.00
Confidence Interval (2-Sided) 90%
267.83 to 465.25
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF­03709270 (1000 mg): Normal Renal Function, PF-03709270 (1000 mg): Severe Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 742.68
Confidence Interval (2-Sided) 90%
529.59 to 1041.50
Estimation Comments [Not Specified]
9.Primary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of CP-70429 Following PF-03709270 Oral Dose
Hide Description 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).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title PF-­03709270 (1000 mg): Normal Renal Function PF­-03709270 (1000 mg): Mild Renal Impairment PF­-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
6523  (1329.5) 13670  (5088.1) 23040  (9403.9) 47990  (16191)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-­03709270 (1000 mg): Normal Renal Function, PF­-03709270 (1000 mg): Mild Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 209.55
Confidence Interval (2-Sided) 90%
158.72 to 276.66
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-­03709270 (1000 mg): Normal Renal Function, PF­-03709270 (1000 mg): Moderate Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 353.26
Confidence Interval (2-Sided) 90%
267.57 to 466.39
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-­03709270 (1000 mg): Normal Renal Function, PF-03709270 (1000 mg): Severe Renal Impairment
Comments A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Geometric Mean Ratio
Estimated Value 735.77
Confidence Interval (2-Sided) 90%
523.56 to 1034.00
Estimation Comments [Not Specified]
10.Primary Outcome
Title Renal Clearance (CLr) of CP-70429 Following PF-03709270 Oral Dose
Hide Description 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).
Time Frame 0 (pre-dose), 0 to 6, 6 to 12, 12 to 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF­-03709270 (1000 mg): Moderate Renal Impairment PF-­03709270: Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Geometric Mean (Standard Deviation)
Unit of Measure: L/hr
15.47  (1.885) 7.952  (2.537) 4.239  (2.647) 3.294  (4.398)
11.Secondary Outcome
Title Terminal Elimination Half Life (t1/2) of CP-70429 Following CP-70,429 Intravenous Dose
Hide Description Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Mean (Standard Deviation)
Unit of Measure: hours
1.034  (0.216) 1.660  (0.586) 1.823  (0.269) 2.313  (0.579)
12.Secondary Outcome
Title Terminal Elimination Half Life (t1/2) of CP-70429 Following PF-03709270 Oral Dose
Hide Description Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF­-03709270 (1000 mg): Moderate Renal Impairment PF-­03709270: Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Mean (Standard Deviation)
Unit of Measure: hours
0.837  (0.121) 1.451  (0.335) 1.809  (0.566) 2.750  (0.832)
13.Secondary Outcome
Title Clearance (CL)
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC 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).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Geometric Mean (Standard Deviation)
Unit of Measure: L/hr
24.87  (3.9001) 14.79  (2.6787) 10.01  (3.7432) 5.648  (1.2500)
14.Secondary Outcome
Title Apparent Oral Clearance (CL/F)
Hide Description 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. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCinf. AUC 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).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Geometric Mean (Standard Deviation)
Unit of Measure: L/hr
153.5  (31.540) 73.20  (24.115) 43.38  (19.719) 20.86  (6.8699)
15.Secondary Outcome
Title Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following Intravenous Dose
Hide Description Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 microgram per milliliter (mcg/mL) at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Median (Full Range)
Unit of Measure: hours
5.310
(3.93 to 5.56)
8.855
(6.23 to 11.1)
11.40
(6.67 to 16.8)
10.70
(6.65 to 16.4)
16.Secondary Outcome
Title Duration of Plasma Concentrations of CP-70429 Exceeding 0.5 Microgram Per Milliliter Following PF-03709270 Oral Dose
Hide Description Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF­-03709270 (1000 mg): Moderate Renal Impairment PF-­03709270: Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Median (Full Range)
Unit of Measure: hours
3.915
(2.76 to 4.88)
6.440
(5.03 to 10.9)
8.185
(5.60 to 11.7)
18.30
(9.48 to 22.0)
17.Secondary Outcome
Title Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following Intravenous Dose
Hide Description Duration was calculated by subtracting the time at which the plasma concentrations exceeded 1.0 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 1.0 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Median (Full Range)
Unit of Measure: hours
3.935
(3.32 to 4.69)
7.190
(5.50 to 7.88)
9.240
(5.65 to 11.6)
7.710
(5.52 to 11.1)
18.Secondary Outcome
Title Duration of Plasma Concentrations of CP-70429 Exceeding 1.0 Microgram Per Milliliter Following PF-03709270 Oral Dose
Hide Description Duration was calculated by subtracting the time at which the plasma concentrations exceeded 0.5 mcg/mL at the ascending part of the concentration-time profile from the time at which the plasma concentrations fell below 0.5 mcg/mL at the descending part of the profile. If these times fell between 2 observed concentrations, a method of linear interpolation was used for best estimation.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF­-03709270 (1000 mg): Moderate Renal Impairment PF-­03709270: Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF­-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-­03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Median (Full Range)
Unit of Measure: hours
2.895
(1.95 to 3.42)
4.990
(3.29 to 8.66)
6.320
(4.47 to 9.72)
12.15
(7.38 to 19.4)
19.Secondary Outcome
Title Pharmacokinetics of CP-70429 and PF-03709270 Metabolites
Hide Description 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 and metabolites.
Time Frame 0.5, 2, 4, 8, 12, 24 hours post-dose (for all participants) and 48 hours post-dose (for participants with moderate and severe renal impairment)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome because the metabolite data for CP-70,429 and PF-03709270 were not analyzed as per change in planned analysis
Arm/Group Title PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Concentration Versus Time Summary of 2-Ethylbutyric Acid
Hide Description Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.
Time Frame 1, 3, 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Mean (Standard Deviation)
Unit of Measure: hours
1 hour 46.38  (96.048) 19.00  (53.740) 15.25  (43.134) NA [1]   (NA)
3 hours 20.00  (56.569) 17.63  (49.851) NA [1]   (NA) NA [1]   (NA)
8 hours NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
No observations above the lower limit of quantification.
21.Secondary Outcome
Title Concentration Versus Time Summary of Plasma Formate
Hide Description Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.
Time Frame 1, 3, 8 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK parameter analysis population included all treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
Arm/Group Title PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 4
Mean (Standard Deviation)
Unit of Measure: hours
1 hour NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
3 hours NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
8 hours NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
No observations above the lower limit of quantification.
22.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame Baseline up to 7-10 days after the last dose of study drug (up to 32 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received the study medication.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (800 mg): Severe Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 1 4 8 8 8 4
Measure Type: Number
Unit of Measure: participants
AEs 5 5 4 0 3 6 4 6 3
SAEs 0 0 0 0 1 0 0 0 0
23.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities
Hide Description Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 6/High Power Field [HPF]).
Time Frame Baseline up to 7-10 days after the last dose of study drug (up to 32 days)
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Hide Analysis Population Description
Safety analysis set included all participants who received the study medication.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (800 mg): Severe Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 1 4 8 8 8 4
Measure Type: Number
Unit of Measure: participants
2 3 7 1 4 1 3 8 4
24.Secondary Outcome
Title Number of Participants With Vital Sign Abnormalities
Hide Description Criteria for vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg, >=20 mmHg maximum increase and decrease from baseline in same posture, heart rate <=45 beats per minute (bpm) or >=120 bpm or decrease/increase of >=15 bpm.
Time Frame Baseline up to 7-10 days after the last dose of study drug (up to 32 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received the study medication.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (800 mg): Severe Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 1 4 8 8 8 4
Measure Type: Number
Unit of Measure: participants
0 0 1 0 1 0 1 2 0
25.Secondary Outcome
Title Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Hide Description Criteria for abnormal ECG (12-lead) values were defined as: maximum PR interval >=300 millisecond (msec) and maximum increase of >=25 percent for baseline value of >200 msec and >=50% for baseline value of <=200 msec for PR interval, QRS interval >=200 msec; QT interval corrected using the Fridericia formula (QTcF) >=500 msec or increase of >45 msec.
Time Frame Baseline up to 7-10 days after the last dose of study drug (up to 32 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received the study medication.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (800 mg): Severe Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 1 4 8 8 8 4
Measure Type: Number
Unit of Measure: participants
0 3 0 0 3 1 4 4 2
26.Secondary Outcome
Title Number of Participants With Change From Baseline in Physical Examinations
Hide Description Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any potential changes in physical status, as determined by the investigator. Any untoward findings identified on physical exams conducted after the administration of the first dose of study medication was captured as an adverse event.
Time Frame Baseline, 7-10 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received the study medication.
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (800 mg): Severe Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal Impairment
Hide Arm/Group Description:
Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period.
Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period.
Overall Number of Participants Analyzed 8 8 8 1 4 8 8 8 4
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 0 0 0 0
Time Frame Baseline up to 7-10 days after the last dose of study drug (up to 32 days)
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (800 mg): Severe Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal
Hide Arm/Group Description Participants with normal renal function (defined by CLcr >80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period. Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period. Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single dose of CP-70,429 800 mg given as an intravenous infusion over 1.5 hours in first intervention period. Participants with severe renal impairment received a single dose of CP-70,429 800 mg given as a 1.5-hour intravenous infusion under fasted condition in first intervention period. Participants with severe renal impairment (defined by CLcr <30 mL/min) received a single dose of CP-70,429 200 mg given as an intravenous infusion over 1.5 hours in first intervention period. Participants with normal renal function (defined by CLcr >80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period. Participants with mild renal impairment (defined by CLcr >50 and <=80 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period. Participants with moderate renal impairment (defined by CLcr >=30 and <=50 mL/min) received a single oral dose of PF-03709270 1000 mg tablet in second intervention period. Participants with severe renal impairment received a single oral dose of PF-03709270 1000 mg tablet under fasted condition in second intervention period.
All-Cause Mortality
CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (800 mg): Severe Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (800 mg): Severe Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/1 (0.00%)   1/4 (25.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/4 (0.00%) 
Injury, poisoning and procedural complications                   
Fall * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Humerus fracture * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CP-70,429 (800 mg): Normal Renal Function CP-70,429 (800 mg): Mild Renal Impairment CP-70,429 (800 mg): Moderate Renal Impairment CP-70,429 (800 mg): Severe Renal Impairment CP-70,429 (200 mg): Severe Renal Impairment PF-03709270 (1000 mg): Normal Renal Function PF-03709270 (1000 mg): Mild Renal Impairment PF-03709270 (1000 mg): Moderate Renal Impairment PF-03709270 (1000 mg): Severe Renal
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/8 (62.50%)   5/8 (62.50%)   4/8 (50.00%)   0/1 (0.00%)   3/4 (75.00%)   6/8 (75.00%)   4/8 (50.00%)   6/8 (75.00%)   3/4 (75.00%) 
Eye disorders                   
Lacrimation increased * 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Vision blurred * 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders                   
Abdominal pain * 1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Abdominal tenderness * 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Diarrhoea * 1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/4 (0.00%)  4/8 (50.00%)  1/8 (12.50%)  2/8 (25.00%)  1/4 (25.00%) 
Dyspepsia * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Faeces discoloured * 1  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Flatulence * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Mucous stools * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/4 (0.00%) 
Nausea * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
General disorders                   
Chest discomfort * 1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Chills * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Feeling jittery * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Infusion site pain * 1  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Infections and infestations                   
Nasopharyngitis * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%) 
Subcutaneous abscess * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Upper respiratory tract infection * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Injury, poisoning and procedural complications                   
Contusion * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Fall * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Rib fracture * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Investigations                   
Blood bilirubin increased * 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Blood glucose decreased * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Urine analysis abnormal * 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders                   
Hypoglycaemia * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Arthralgia * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Back pain * 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Pain in extremity * 1  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Nervous system disorders                   
Headache * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  3/8 (37.50%)  1/4 (25.00%) 
Syncope * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Dizziness * 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Renal and urinary disorders                   
Urine odour abnormal * 1  4/8 (50.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  3/8 (37.50%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders                   
Nasal congestion * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Oropharyngeal pain * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Respiratory tract congestion * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%) 
Skin and subcutaneous tissue disorders                   
Cold sweat * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Hyperhidrosis * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Pruritus * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Swelling face * 1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%) 
Vascular disorders                   
Angiopathy * 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
Flushing * 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/1 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00759564     History of Changes
Other Study ID Numbers: A8811009
2009-017796-20 ( EudraCT Number )
First Submitted: September 23, 2008
First Posted: September 25, 2008
Results First Submitted: December 11, 2015
Results First Posted: January 18, 2016
Last Update Posted: March 11, 2016