Healthy Subjects
Conditions
Brief 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.
Detailed description
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).
Interventions
DRUGTR-701 FA
TR-701 FA 200 mg once daily
Sponsors
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 6 weeks | 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. |
Countries
United States
Outcome results
None listed