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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-110 | Other Identifier | TriusRX unique ID |
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This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701 FA once daily for 10 days and will include ophthalmologic and neurologic assessments.
This is a Phase 1 open-label study in healthy volunteers who will receive oral 200 mg TR 701 FA once daily for 10 days (Days 1 through 10) and undergo safety evaluations including ophthalmologic and neurologic assessments before (Screening or Day -1), 1 day after final study drug administration (Day 11 or earlier if a subject discontinues treatment), and 2 to 4 weeks after the last study drug administration (Late Follow-up Visit).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TR-701 FA | Experimental | TR-701 FA 200 mg oral once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TR-701 FA | Drug | TR-701 FA 200 mg once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety | The primary objective is to determine the safety of oral 200 mg TR-701 free acid (FA) administered once daily for 10 days in healthy adults. Safety outcome measures include the number and proportion of participants with adverse events, changes in vital signs and ECG, and evaluation of physical examination changes including neurologic and ophthalmologic exams. | 6 weeks |
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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 | Dallas | Texas | 75247 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27941424 | Result | Fang E, Munoz KA, Prokocimer P. Characterization of Neurologic and Ophthalmologic Safety of Oral Administration of Tedizolid for Up to 21 Days in Healthy Volunteers. Am J Ther. 2017 Mar/Apr;24(2):e227-e233. doi: 10.1097/MJT.0000000000000534. |
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| ID | Term |
|---|---|
| C515040 | tedizolid phosphate |
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