Food Effects of Single Oral Dose of 600mg TR-701

Study Overview
=================
Brief Summary
-----------------
This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.

Detailed Description
-----------------
Subjects will receive the following treatments in a crossover design: Treatment A: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water after at least a 10-hour fast. Treatment B: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water following a high-fat meal preceded by at least a 10-hour fast. Descriptive statistics will be calculated for PK parameters where available, including Cmax, Tmax, AUC0-t, and AUC0-inf. Minimum, maximum, mean, and median values will be determined and standard deviations will be calculated. Where data are available, food effect will be examined between test (fed state) and reference (fasted state) groups.

Official Title
-----------------
An Open-Label, Single-Dose, Two-Treatment, Randomized, Two-Way Crossover, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults in the Fed and Fasted State

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: TR-701 600mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI of 20 to 29.9 kg/m2 Females must be either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or agree to use an acceptable method of birth control Exclusion Criteria: history or clinical manifestations of any clinically significant medical 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 pregnancy, lactation, or breastfeeding 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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: after fast<br>Administration of a single oral dose of 600mg TR-701 to subjects in the fasted state. | Drug: TR-701 600mg<br>* TR-701 600mg<br>|
| Experimental: After high fat food<br>Administration of a single oral dose of 600mg TR-701 to subjects in the fed state. | Drug: TR-701 600mg<br>* TR-701 600mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of TR-701 600mg given as a single oral dose. |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of single doses of TR-701 and its microbiologically active moiety, TR-700, in healthy adult volunteers in the fed and fasted state |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food effects