Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double-Blind, Placebo and Active Controlled, Single and Multiple Rising Dose, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: TR-701
* Drug: linezolid
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Drug: TR-701<br>* TR-701 will be given as single oral doses in Cohorts 1-5 and as once daily oral doses for 21 days in cohorts 6-8.<br>|
| Placebo Comparator: 2<br>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. | Drug: placebo<br>* Placebo will be given once for cohorts 1-5, once daily for 21 days for cohorts 6-8, and twice daily for 21 days for cohort 10.<br>|
| Active Comparator: 3<br>Oral doses of 600mg linezolid given twice daily for 21 days. | Drug: linezolid<br>* Linezolid will be given at 600 mg twice daily for 21 days in cohort 10.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event reporting |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The PK rate and extent of urinary excretion of TR-701 and its microbiologically active moiety, TR-700 |  | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibiotic