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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-102 | Other Identifier | TrisuRX Unique ID |
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The purpose of this study is to measure the penetration of TR-700 into subcutaneous adipose tissue and skeletal muscle after a single oral dose of 600 mg TR-701
This study will be conducted in two parts: a Pilot Study and a Main Study. The Pilot Study will be conducted to assess recovery of exogenously administered TR-700 (microbiologically active moiety) via microdialysis. In the Main Study, pharmacokinetics of TR-700 will be determined in both soft tissues (via microdialysis) and plasma after a single oral dose of 600 mg TR-701 (prodrug).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot study | Experimental | 3 subjects, open lable, microdialysis single dose. |
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| Main Study | Experimental | 12 subjects, open label, single dose of 600 mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR-700 (active moiety) | Drug | A TR-700 solution will be locally administered via a microdialysis probe into the skeletal muscle and subcutanous tissue (just under the skin) at a concentration of approximately 2 µg/mL at a flow rate of 1.5 µL/min for 60 minutes for a total maximum dose of 0.36 µg (0.18 µg per probe). |
| Measure | Description | Time Frame |
|---|---|---|
| Subcutaneous tissue concentrations of TR-700 | Single day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harmut Derendorf, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Center | Gainesville | Florida | 32604 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22584101 | Result | Sahre M, Sabarinath S, Grant M, Seubert C, Deanda C, Prokocimer P, Derendorf H. Skin and soft tissue concentrations of tedizolid (formerly torezolid), a novel oxazolidinone, following a single oral dose in healthy volunteers. Int J Antimicrob Agents. 2012 Jul;40(1):51-4. doi: 10.1016/j.ijantimicag.2012.03.006. Epub 2012 May 13. |
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| ID | Term |
|---|---|
| C546016 | tedizolid |
| C515040 | tedizolid phosphate |
| D011355 | Prodrugs |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| TR-701 (pro-drug) | Drug | Each subject enrolled in the Main study will receive a single oral dose of 600mg TR-701 |
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