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The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy controls | Experimental | healthy subjects (creatinine clearance > 90 mL/min) |
|
| ESRD / severe renal insufficiency | Experimental | Severe (creatinine clearance 15 to 29 mL/min) OR ESRD (creatinine clearnace <15 mL/min OR requiring dialysis) |
|
| Moderate renal impairment | Experimental | Moderate (creatinine clearance = 30 to 59 mL/min) |
|
| Mild renal impairment | Experimental | Mild (creatinine clearance = 60 to 89 mL/min) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04991532 | Drug | single dose 300-mg |
| |
| PF-04991532 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUClast) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs | |
| Maximum observed plasma concentration (Cmax) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs | |
| Time of maximum observed plasma concentration (Tmax) | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs | |
| Renal Clearance (Clr) | 0 to 24 hours | |
| Amount of drug excreted (Ae) | 0 to 24 hours |
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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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anaheim | California | 92801 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C571532 | 6-(3-cyclopentyl-2-(4-(trifluoromethyl)-1H-imidazol-1-yl)propanamido)nicotinic acid |
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| Drug |
single dose 300-mg |
|
| PF-04991532 | Drug | single dose 300-mg |
|
| PF-04991532 | Drug | single dose 300-mg |
|
| DeLand |
| Florida |
| 32720 |
| United States |
| D004700 | Endocrine System Diseases |