Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult subjects and to assess the relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule.

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

Details

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

Criteria

Inclusion Criteria:

• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs;

• Females will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or agree to use an acceptable form of contraception

• BMI of 18.5 to 32.0 kg/m2, inclusive

Exclusion Criteria:

• Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder

• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance

• Pregnancy, lactation, or breastfeeding