A Phase 1, Open-Label, 10 Day Safety Study
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Phase 1, Open-Label, Ophthalmology and Neurology Safety Study of Oral 200 mg TR-701 FA Once Daily for 10 Days in Healthy Adults|
- Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: TR-701 FA
TR-701 FA 200 mg oral once daily
Drug: TR-701 FA
TR-701 FA 200 mg once daily
Other Name: Tedizolid Phosphate
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623401
|United States, Texas|
|Trius Investigator Site 001|
|Dallas, Texas, United States, 75247|
|Study Chair:||Philippe G Prokocimer, MD||Trius Therapeutics|