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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-106 | Other Identifier | TriusRX unique Id |
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The purpose of this study is to describe the single dose pharmacokinetics of total radioactivity in plasma and whole blood following PO administration of [14C] TR-701 in healthy adult male subjects.
This study will be an open-label, single-dose study of the absorption, metabolism, and excretion of 200 mg [14C]-TR-701 (approximately 100 μCi) administered orally following at least an 8-hour fast. Subjects will receive a single dose of 200 mg [14C] TR 701 (approximately 100 μCi) administered as an oral solution.
The dose will be administered following at least an 8-hour fast and followed by a 4-hour fast from food, not including water.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human ADME | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human ADME | Drug | Oral single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| To describe the single dose plasma PK of TR-700, the microbiologically active molecule | To describe the single dose pharmacokinetics (Cmax, Tmax, AUC, t 1/2, CL/F) of total radioactivity in plasma, whole blood, urine and feces following oral (PO) administration of [14C] TR 701 in healthy adult male subjects | pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, then daily up to 312 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe G Prokocimer, MD | Trius Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trius Investigator Site 001 | Madison | Wisconsin | 53704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24875463 | Result | Ong V, Flanagan S, Fang E, Dreskin HJ, Locke JB, Bartizal K, Prokocimer P. Absorption, distribution, metabolism, and excretion of the novel antibacterial prodrug tedizolid phosphate. Drug Metab Dispos. 2014 Aug;42(8):1275-84. doi: 10.1124/dmd.113.056697. Epub 2014 May 29. |
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