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

• Status: Completed
• Trial end date: 2008-06-06
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Trius Therapeutics LLC
• Treatments: Linezolid; Torezolid phosphate

Criteria

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