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The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-00734200 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-00734200 | Drug | The drug is administered as a single dose of four 5-mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve from time 0 until last observation (AUCtlast) | 3-6 days | |
| Maximum serum concentration (Cmax) | 3-6 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC extrapolated to infinity (AUCinf) | 3-6 days | |
| Time of Cmax (Tmax) | 3-6 days | |
| Half life (T1/2) |
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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 | Miami | Florida | 33169 | United States | ||
| Pfizer Investigational Site |
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| 3-6 days |
| Renal clearance (CLr) | 3-6 days |
| Hemodialysis clearance (CLd) | 3 days |
| Orlando |
| Florida |
| 32809 |
| United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| Pfizer Investigational Site | Knoxville | Tennessee | 37920 | United States |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C558848 | gosogliptin |
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