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

• Status: Completed
• Trial end date: 2012-08-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Trius Therapeutics LLC
• Treatments: Tedizolid; Tedizolid phosphate; Torezolid phosphate

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