Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Subjects

In brief

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single rising oral doses and multiple oral doses of TR-701

Key facts

Study ID

NCT00671814

Run by

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

People needed

80

Starts

2008-01-06

Expected to finish

2008-06-06

Last updated by the study team

2017-08-31

Who can join

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

You may qualify if…

• in good health
• body mass index of 20 to 29.9 kg/m2
• female subjects must be either postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to use an effective method of birth control

You may not qualify if…

• history or clinical manifestations of any clinically significant 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
• 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
• pregnancy, lactation, or breastfeeding

Where it is running

• Covance Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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