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A Phase 1, Open-Label, 10 Day Safety Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01623401
First Posted: June 20, 2012
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Trius Therapeutics LLC
June 6, 2012
June 20, 2012
October 6, 2017
May 17, 2012
August 24, 2012   (Final data collection date for primary outcome measure)
Safety [ Time Frame: 6 weeks ]
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.
Same as current
Complete list of historical versions of study NCT01623401 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase 1, Open-Label, 10 Day Safety Study
Phase 1, Open-Label, Ophthalmology and Neurology Safety Study of Oral 200 mg TR-701 FA Once Daily for 10 Days in Healthy Adults
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).
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Healthy Subjects
Drug: TR-701 FA
TR-701 FA 200 mg once daily
Other Name: Tedizolid Phosphate
Experimental: TR-701 FA
TR-701 FA 200 mg oral once daily
Intervention: Drug: TR-701 FA
Fang E, Muñoz 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
August 24, 2012
August 24, 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males and females ≥ 18 and ≤ 65 years of age with no clinically significant abnormalities identified by a detailed medical history
  • Female subjects must be nonpregnant, nonlactating, and either postmenopausal for at least 2 years, surgically sterile for at least 90 days, abstinent, or agree to use contraception from 1 week prior to Day -1 until 30 days after leaving the study center.
  • Male subjects must be surgically sterile, abstinent, or agree to use contraception from Day -1 until 30 days after leaving the study center
  • BMI ≥ 18.0 kg/m2 and ≤ 35.0 kg/m2

Exclusion Criteria:

  • Hypersensitivity to oxazolidinones or any component in the formulation
  • History or current significant ophthalmologic or neurologic condition that would adversely affect the clinical assessments or confound the interpretation of the data (e.g., dense cataracts, macular degeneration, retinitis pigmentosa)
  • Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody test result
  • Known genetic condition related to mitochondrial disease or dysfunction
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01623401
1986-030
TR701-110 ( Other Identifier: TriusRX unique ID )
No
Not Provided
Not Provided
Trius Therapeutics LLC
Trius Therapeutics LLC
Not Provided
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
Trius Therapeutics LLC
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP