Trial Outcomes & Findings for PF-04634817 Renal Impairment Study (NCT NCT01791855)
NCT ID: NCT01791855
Last Updated: 2024-03-01
Results Overview
AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48hours.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dose
Results posted on
2024-03-01
Participant Flow
Participant milestones
| Measure |
Normal Renal Function
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
8
|
7
|
|
Overall Study
Treated
|
8
|
8
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Normal Renal Function
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Randomized, not treated
|
0
|
1
|
0
|
0
|
Baseline Characteristics
PF-04634817 Renal Impairment Study
Baseline characteristics by cohort
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.0 Years
STANDARD_DEVIATION 5.2 • n=93 Participants
|
66.5 Years
STANDARD_DEVIATION 3.9 • n=4 Participants
|
61.9 Years
STANDARD_DEVIATION 3.2 • n=27 Participants
|
59.0 Years
STANDARD_DEVIATION 12.0 • n=483 Participants
|
61.9 Years
STANDARD_DEVIATION 7.5 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
19 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dosePopulation: The pharmacokinetics (PK) parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest.
AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48hours.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to 48 Hours[AUC (0 - 48)]
|
1294 Nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 27
|
1399 Nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 42
|
2024 Nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 35
|
2860 Nanogram*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 34
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dosePopulation: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
1467 ng*h/mL
Geometric Coefficient of Variation 29
|
1575 ng*h/mL
Geometric Coefficient of Variation 44
|
2610 ng*h/mL
Geometric Coefficient of Variation 42
|
3845 ng*h/mL
Geometric Coefficient of Variation 37
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dosePopulation: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. N = number of participants with reportable AUC(0-inf) values.
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]
|
1473 ng*h/mL
Geometric Coefficient of Variation 29
|
1584 ng*h/mL
Geometric Coefficient of Variation 44
|
2611 ng*h/mL
Geometric Coefficient of Variation 45
|
3877 ng*h/mL
Geometric Coefficient of Variation 37
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dosePopulation: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. N = the number of participants with reportable CL/F values.
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. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F)
|
565.8 milliliter/minute (mL/min)
Geometric Coefficient of Variation 29
|
526.8 milliliter/minute (mL/min)
Geometric Coefficient of Variation 44
|
319.2 milliliter/minute (mL/min)
Geometric Coefficient of Variation 45
|
215.2 milliliter/minute (mL/min)
Geometric Coefficient of Variation 37
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dosePopulation: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
124.6 ng/mL
Geometric Coefficient of Variation 49
|
111.4 ng/mL
Geometric Coefficient of Variation 66
|
123.7 ng/mL
Geometric Coefficient of Variation 59
|
132.3 ng/mL
Geometric Coefficient of Variation 59
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dosePopulation: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
2.01 hours
Interval 1.5 to 3.0
|
2.50 hours
Interval 1.0 to 8.0
|
2.00 hours
Interval 1.5 to 8.0
|
3.00 hours
Interval 1.0 to 12.0
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dosePopulation: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. N = the number of participants with reportable Vz/F values.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
1453 Liter (L)
Geometric Coefficient of Variation 35
|
1808 Liter (L)
Geometric Coefficient of Variation 38
|
1162 Liter (L)
Geometric Coefficient of Variation 57
|
742.3 Liter (L)
Geometric Coefficient of Variation 53
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 hours post dosePopulation: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. N = the number of participants with reportable t1/2 values.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Plasma Decay Half-Life (t1/2)
|
31.01 hours
Standard Deviation 11.33
|
43.94 hours
Standard Deviation 24.40
|
43.57 hours
Standard Deviation 11.89
|
44.94 hours
Standard Deviation 23.96
|
SECONDARY outcome
Timeframe: 0-24, 24-48 hours post dosePopulation: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest.
Amount of unchanged drug excreted in urine over 48 hours (Ae48) = urine concentration x volume of urine.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Amount of Unchanged Drug Excreted in Urine Over 48 Hours (Ae48)
|
9303000 ng
Geometric Coefficient of Variation 48
|
5993000 ng
Geometric Coefficient of Variation 47
|
4997000 ng
Geometric Coefficient of Variation 26
|
3097000 ng
Geometric Coefficient of Variation 65
|
SECONDARY outcome
Timeframe: 0-24, 24-48 post dosePopulation: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Note that the measure of dispersion should be simply coefficient of variation (CV) instead of geometric CV (GCV) for Ae48%. GCV was chosen due to absence of CV in the options given for that field.
Percentage (%) of drug excreted unchanged in urine over 48 hours (Ae48%) = Ae48/(dose x 100).
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Percentage of the Dose Excreted Unchanged in the Urine Over 48 Hours (Ae48%)
|
18.61 percentage of unchanged drug excreted
Geometric Coefficient of Variation 44
|
12.00 percentage of unchanged drug excreted
Geometric Coefficient of Variation 43
|
9.989 percentage of unchanged drug excreted
Geometric Coefficient of Variation 25
|
6.193 percentage of unchanged drug excreted
Geometric Coefficient of Variation 62
|
SECONDARY outcome
Timeframe: 0-24, 24-48 hours post dosePopulation: The PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest.
Renal clearance over a 48-hour interval (CLr48) = Ae48/AUC48.
Outcome measures
| Measure |
Normal Renal Function
n=8 Participants
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=8 Participants
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 Participants
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Renal Clearance Over a 48-hour Interval(CLr48)
|
119.8 mL/min
Geometric Coefficient of Variation 39
|
71.40 mL/min
Geometric Coefficient of Variation 41
|
41.13 mL/min
Geometric Coefficient of Variation 36
|
18.05 mL/min
Geometric Coefficient of Variation 59
|
Adverse Events
Normal Renal Function
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mild Renal Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Renal Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Severe Renal Impairment
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Normal Renal Function
n=8 participants at risk
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 participants at risk
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=8 participants at risk
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 participants at risk
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
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, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Normal Renal Function
n=8 participants at risk
An oral dose of PF-04634817 50 milligram (mg) was administered to participants with normal renal function (defined as a creatinine clearance \[CrCL\] of more than or equal \[\>=\] to 90 milligrams \[mL\]/minute \[min\], estimated using the Cockcroft-Gault Equation).
|
Mild Renal Impairment
n=8 participants at risk
An oral dose of PF-04634817 50 mg was administered to participants with mild renal impairment (defined as a CrCL of 60 to 89 mL/min, estimated using the Cockcroft-Gault Equation).
|
Moderate Renal Impairment
n=8 participants at risk
An oral dose of PF-04634817 50 mg was administered to participants with moderate renal impairment (defined as a CrCL of 30 to 59 mL/min, estimated using the Cockcroft-Gault Equation).
|
Severe Renal Impairment
n=7 participants at risk
An oral dose of PF-04634817 50 mg was administered to participants with severe renal impairment (defined as a CrCL of 15 to 29 mL/min, estimated using the Cockcroft-Gault Equation).
|
|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
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, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
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, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7
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, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
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, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
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, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
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, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
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, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
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, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
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, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/8
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, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7
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, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER