Status:
COMPLETED
Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Bacterial Infections
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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...
Detailed Description
SAD/Part A. * All subjects in the Pilot Cohort will receive a single infusion of 50 mg TR-701 FA for injection in 250 cc of saline over 180 minutes. * Subjects in Cohort 1 will be randomized to recei...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00983255
Start Date
September 1 2009
End Date
January 1 2010
Last Update
May 19 2016
Active Locations (1)
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1
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704