Healthy Subjects Clinical Trial
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
Verified date | October 2017 |
Source | Trius Therapeutics LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | August 24, 2012 |
Est. primary completion date | August 24, 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Trius Investigator Site 001 | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Trius Therapeutics LLC |
United States,
Fang E, Muñoz KA, Prokocimer P. Characterization of Neurologic and Ophthalmologic Safety of Oral Administration of Tedizolid for Up to 21 Days in Healthy Volunteers. Am J Ther. 2017 Mar/Apr;24(2):e227-e233. doi: 10.1097/MJT.0000000000000534. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | 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. | 6 weeks |
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