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

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID

NCT01623401

Run by

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

72

Starts

2012-05-17

Expected to finish

2012-08-24

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Trius Investigator Site 001 — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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