Food Effects of Single Oral Dose of 600mg TR-701

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00671359

Run by

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

12

Starts

2008-03-10

Expected to finish

2008-05-15

Last updated by the study team

2018-04-04

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance CRU — San Diego, California, United States

Full record on ClinicalTrials.gov

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