Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising and multiple rising IV doses of TR-701 FA and to determine the absolute bioavailability of oral TR-701 FA following single oral and IV dose administrations in healthy adult subjects.

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

Details

• Lead Sponsor: Trius Therapeutics LLC
• Treatments: Oxazolidinones; Tedizolid; Tedizolid phosphate; Torezolid; Torezolid phosphate

Criteria

Inclusion Criteria:

• in good health

• body mass index of 20 to 29.9 kg/m2

• female subjects must be post menopausal for at least 1 year, surgically sterile, abstinent or agree to use an effective method of birth control

Exclusion Criteria:

• history or clinical manifestation of any clinically significant disorder

• history of hypersensitivity to any drug compound

• history of stomach or intestinal surgery or resection

• history of infections of unexplained frequency or severity

• history of alcoholism or drug addiction within 1 year

• use of any tobacco- or nicotine-containing products within 6 months

• use of alcohol-, grapefruit-, caffeine-, or high tyramine-containing foods or beverages

• use of any other medications

• pregnancy, lactation, or breastfeeding