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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-123 | Other Identifier | TriusRX Unique ID |
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The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.
To assess the pharmacokinetics (PK) and evaluate the safety of intravenous (IV) infusion of TR-701 free acid (FA) in subjects with advanced renal impairment compared with matched control subjects with normal renal function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Impairment Nondialyzed | Experimental |
| |
| Renal Impairment Dialyzed | Experimental |
| |
| Matched Control | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR-701 FA single infusion | Drug | Single IV infusion, 200 mg daily for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite (or Profile) of Pharmacokinetics | Cmax, Area Under Curve, Tmax t1/2 will be compared between each renal group and the control group, including calculation of geometric mean ratio and corresponding 90% confidence intervals. | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Prokocimer, MD | Trius Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trius Investigator Site 001 | Orlando | Florida | 32809 | United States | ||
| Trius Investigator Site 002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25136024 | Derived | Flanagan S, Minassian SL, Morris D, Ponnuraj R, Marbury TC, Alcorn HW, Fang E, Prokocimer P. Pharmacokinetics of tedizolid in subjects with renal or hepatic impairment. Antimicrob Agents Chemother. 2014 Nov;58(11):6471-6. doi: 10.1128/AAC.03431-14. Epub 2014 Aug 18. |
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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 |
|---|---|
| C546016 | tedizolid |
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| TR-701 FA | Drug | Two separate infusions of 200 mg |
|
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| TR-701 FA | Drug | Single IV infusion, 200 mg daily for 7 days |
|
|
| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |