Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg

• Status: Completed
• Trial end date: 2011-01-03
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.

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

Details

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

Criteria

Inclusion Criteria:

• Healthy males and females, between 18 and 55 years of age, inclusive

• Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control

• Males must be surgically sterile, abstinent, or practicing an effective method of birth control

• BMI between 20 and 34.9 kg/m2, inclusive

Exclusion Criteria:

• Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes

• Physician-diagnosed migraine headaches within 3 years

• Previous enrollment in a TR-701 or TR-701 FA trial