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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-103 | Other Identifier | TriusRX Unique ID |
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This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.
Subjects will receive the following treatments in a crossover design:
Treatment A: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water after at least a 10-hour fast.
Treatment B: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water following a high-fat meal preceded by at least a 10-hour fast.
Descriptive statistics will be calculated for PK parameters where available, including Cmax, Tmax, AUC0-t, and AUC0-inf. Minimum, maximum, mean, and median values will be determined and standard deviations will be calculated. Where data are available, food effect will be examined between test (fed state) and reference (fasted state) groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| after fast | Experimental | Administration of a single oral dose of 600mg TR-701 to subjects in the fasted state. |
|
| After high fat food | Experimental | Administration of a single oral dose of 600mg TR-701 to subjects in the fed state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR-701 600mg | Drug | TR-701 600mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety and tolerability of TR-701 600mg given as a single oral dose. | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of single doses of TR-701 and its microbiologically active moiety, TR-700, in healthy adult volunteers in the fed and fasted state | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Berry, MD | Covance CRU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance CRU | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23926058 | Derived | Flanagan SD, Bien PA, Munoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7. |
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| ID | Term |
|---|---|
| C515040 | tedizolid phosphate |
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