Status:
COMPLETED
Food Effects of Single Oral Dose of 600mg TR-701
Lead Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.
Detailed Description
Subjects will receive the following treatments in a crossover design: Treatment A: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water after at le...
Eligibility Criteria
Inclusion
- BMI of 20 to 29.9 kg/m2
- Females must be either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or agree to use an acceptable method of birth control
Exclusion
- history or clinical manifestations of any clinically significant medical disorder
- history of hypersensitivity or allergies to any drug compound
- history of stomach or intestinal surgery or resection
- history of alcoholism or drug addiction within 1 year
- pregnancy, lactation, or breastfeeding
- use of any tobacco-containing or nicotine-containing products within 6 months
- use of any other medications
- use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages; or foods or beverages with high levels of tyramine
Key Trial Info
Start Date :
March 10 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00671359
Start Date
March 10 2008
End Date
May 15 2008
Last Update
April 4 2018
Active Locations (1)
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1
Covance CRU
San Diego, California, United States, 92123