Status:
COMPLETED
Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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...
Detailed Description
Subjects will receive the following treatments in a crossover design: Treatment A (Reference): One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700) administered orally ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00876655
Start Date
February 1 2009
End Date
March 1 2009
Last Update
May 3 2016
Active Locations (1)
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1
Covance Clinical Research Unit
Austin, Texas, United States, 78752