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

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.
ClinicalTrials.gov Identifier: NCT01623401
Recruitment Status : Completed
First Posted : June 20, 2012
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: TR-701 FA Phase 1

Detailed Description:
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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : May 17, 2012
Primary Completion Date : August 24, 2012
Study Completion Date : August 24, 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623401


Locations
United States, Texas
Trius Investigator Site 001
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Trius Therapeutics LLC
Investigators
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
More Information

Publications:
Responsible Party: Trius Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01623401     History of Changes
Other Study ID Numbers: 1986-030
TR701-110 ( Other Identifier: TriusRX unique ID )
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Torezolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents