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

June 6, 2012
December 5, 2012
May 2012
August 2012   (final data collection date for primary outcome measure)
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.
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
August 2012
August 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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01623401
TR701-110
No
Trius Therapeutics, Inc.
Trius Therapeutics, Inc.
Not Provided
Study Chair: Philippe G Prokocimer, MD Trius Therapeutics
Trius Therapeutics, Inc.
April 2012

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