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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01623401
First received: June 6, 2012
Last updated: December 5, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Healthy Subjects
Drug: TR-701 FA
Phase 1

Study Type: Interventional
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

Further study details as provided by Trius Therapeutics, Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 72
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623401

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

No publications provided

Responsible Party: Trius Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01623401     History of Changes
Other Study ID Numbers: TR701-110
Study First Received: June 6, 2012
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 15, 2014