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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-107 | Other Identifier | TriusRX Unique ID |
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising and multiple rising IV doses of TR-701 FA and to determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects.
SAD/Part A.
MAD/Part B
BA/Part C
Venous Tolerability/Part D
- Subjects in Cohort 8 will receive once daily 60 minute infusions of 200 mg TR-701 FA for injection in 250 cc of saline for 3 days and once daily placebo infusions for 3 daysin a blinded crossover design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD/ Part A | Experimental | Single IV infusions of placebo or TR-701 FA given at 50, 100, 200, and 400 mg. |
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| MAD / Part B | Experimental | Multiple IV infusion of placebo or TR-701 FA given daily for 7 days at 200 and 400 mg. |
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| Bioavailability / Part C | Experimental | TR-701 FA tablet given once orally as a 200 mg tablet or TR-701 FA for injection given once as a 200 mg IV infusion. |
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| Venous Tolerability/ Part D | Experimental | IV infusions of placebo and 200 mg TR-701 FA given daily for 3 days, |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR-701 FA for injection, 200 mg/vial | Drug | TR-701 FA for injection will be given as a single infusion at doses of 50 mg, 100 mg, 200 mg, and 400 mg in SAD/Part A (Pilot and Cohorts 1 to 3). TR-701 FA for injection will be given as once daily infusions at doses of 200 mg and 400 mg for 7 days in MAD/Part B (Cohorts 4 & 5). TR-701 FA for injection will be given once as a 200 mg IV infusion in BA/Part C (Cohort 6). TR-701 FA 200 mg will be given daily for 3 days in Venous Tolerability/Part D |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessments | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of TR-701 and its microbiologically active moiety TR-700 after single and multiple IV doses of TR-701 FA | 10 days | |
| To determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Siebers, MD | Covance Clinical Research Unit, Madison, WI, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24989138 | Derived | Flanagan S, Fang E, Munoz KA, Minassian SL, Prokocimer PG. Single- and multiple-dose pharmacokinetics and absolute bioavailability of tedizolid. Pharmacotherapy. 2014 Sep;34(9):891-900. doi: 10.1002/phar.1458. Epub 2014 Jul 3. |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007267 | Injections |
| C515040 | tedizolid phosphate |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| TR-701 FA tablets | Drug | TR-701 FA will be given once orally as a 200 mg tablet in Part C. |
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| 4 days |