A Phase 1, Open-Label, 10 Day Safety Study (NCT01623401) | Clinical Trial Compass
CompletedPhase 1
A Phase 1, Open-Label, 10 Day Safety Study
United States72 participantsStarted 2012-05-17
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Safety
Timeframe: 6 weeks
Trial details
NCT IDNCT01623401
SponsorTrius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)