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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000360-29 | EudraCT Number |
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Patients with renal impairment are the target population for PF-04634817. The clearance mechanism of this drug means that exposure may be increased in subjects with renal impairment. This study will investigate the effect of the drug in subjects with varying degrees of renal impairment. Pharmacokinetics, safety and toleration will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental |
| |
| Mild Renal Impairment | Experimental |
| |
| Moderate renal impairment | Experimental |
| |
| Severe renal impairment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04634817 | Drug | Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to 48 Hours[AUC (0 - 48)] | AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48hours. | 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 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | 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 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] | AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. | 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 |
| Apparent Oral Clearance (CL/F) | 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. | 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 |
| Maximum Observed Plasma Concentration (Cmax) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Unchanged Drug Excreted in Urine Over 48 Hours (Ae48) | Amount of unchanged drug excreted in urine over 48 hours (Ae48) = urine concentration x volume of urine. | 0-24, 24-48 hours post dose |
| Percentage of the Dose Excreted Unchanged in the Urine Over 48 Hours (Ae48%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States | ||
| Unversity of Miami |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31566438 | Derived | Tesch GH, Pullen N, Jesson MI, Schlerman FJ, Nikolic-Paterson DJ. Combined inhibition of CCR2 and ACE provides added protection against progression of diabetic nephropathy in Nos3-deficient mice. Am J Physiol Renal Physiol. 2019 Dec 1;317(6):F1439-F1449. doi: 10.1152/ajprenal.00340.2019. Epub 2019 Sep 30. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis included the participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve From Time Zero to 48 Hours[AUC (0 - 48)] | AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48hours. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/milliliter (ng*h/mL) | 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 |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
Designation of primary and secondary endpoints was based on the discretion of the study team, as the endpoints were not characterized clearly in the study protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000629947 | PF-04634817 |
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| PF-04634817 | Drug | Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min) |
|
| PF-04634817 | Drug | Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min) |
|
| PF-04634817 | Drug | Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min) |
|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 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 |
| Apparent Volume of Distribution (Vz/F) | 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. | 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 |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 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 |
Percentage (%) of drug excreted unchanged in urine over 48 hours (Ae48%) = Ae48/(dose x 100). |
| 0-24, 24-48 post dose |
| Renal Clearance Over a 48-hour Interval(CLr48) | Renal clearance over a 48-hour interval (CLr48) = Ae48/AUC48. | 0-24, 24-48 hours post dose |
| Miami |
| Florida |
| 33136 |
| United States |
| Randomized, not treated |
|
| 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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). |
| OG002 | 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). |
| OG003 | 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). |
|
|
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 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 |
|
|
|
| Primary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] | AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 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 |
|
|
|
| Primary | Apparent Oral Clearance (CL/F) | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | milliliter/minute (mL/min) | 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 |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
|
|
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 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. | Posted | Median | Full Range | hours | 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 |
|
|
|
| Primary | Apparent Volume of Distribution (Vz/F) | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | 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 |
|
|
|
| Primary | Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 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. | Posted | Mean | Standard Deviation | hours | 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 |
|
|
|
| Secondary | Amount of Unchanged Drug Excreted in Urine Over 48 Hours (Ae48) | Amount of unchanged drug excreted in urine over 48 hours (Ae48) = urine concentration x volume of urine. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng | 0-24, 24-48 hours post dose |
|
|
|
| Secondary | Percentage of the Dose Excreted Unchanged in the Urine Over 48 Hours (Ae48%) | Percentage (%) of drug excreted unchanged in urine over 48 hours (Ae48%) = Ae48/(dose x 100). | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of unchanged drug excreted | 0-24, 24-48 post dose |
|
|
|
| Secondary | Renal Clearance Over a 48-hour Interval(CLr48) | Renal clearance over a 48-hour interval (CLr48) = Ae48/AUC48. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 0-24, 24-48 hours post dose |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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). | 0 | 8 | 0 | 8 |
| EG002 | 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). | 0 | 8 | 0 | 8 |
| EG003 | 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). | 1 | 7 | 3 | 7 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
|
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.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |