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

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

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

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.

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