A Double-Blind, Placebo and Active Controlled, Single and Multiple Rising Dose, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Adverse Event reporting
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising oral doses and multiple oral doses of TR-701
Detailed Description
This is an evaluation of TR-701 in a double-blind, placebo-controlled, randomized, single (Part A) and multiple (Part B) ascending dose safety, tolerance, and PK when administered as a capsule in normal, healthy adult volunteers. The study will be sequential between Part A and Part B (i.e., not staggered or leap frogged), with slight overlap between last cohort in Part A and first cohort in Part B.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •in good health
- •body mass index of 20 to 29.9 kg/m2
- •female subjects must be either postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to use an effective method of birth control
Exclusion Criteria
- •history or clinical manifestations of any clinically significant disorder
- •history of hypersensitivity or allergies to any drug compound
- •history of stomach or intestinal surgery or resection
- •history of alcoholism or drug addiction within 1 year
- •use of any tobacco-containing or nicotine-containing products within 6 months
- •use of any other medications
- •use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages; or foods or beverages with high levels of tyramine
- •pregnancy, lactation, or breastfeeding
Arms & Interventions
1
Single oral dose of TR-701 given once at 200mg, 400mg, 600mg, 800mg, and 1200mg. Multiple oral doses of TR-701 given once daily for 21 days at 200mg, 300mg and 400mg.
Intervention: TR-701 (Drug)
2
Single oral dose of placebo given in cohorts 1-5. Multiple oral doses of placebo given once daily for 21 days in cohorts 6-8 and twice daily for 21 days in cohort 10.
Intervention: placebo (Drug)
3
Oral doses of 600mg linezolid given twice daily for 21 days.
Intervention: linezolid (Drug)
Outcomes
Primary Outcomes
Adverse Event reporting
Time Frame: 21 days
Secondary Outcomes
- The PK rate and extent of urinary excretion of TR-701 and its microbiologically active moiety, TR-700(21 days)