Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)

Completed · Phase 1

Conditions studied: Bacterial Infections

In brief

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 TR-701 FA following single oral and IV dose administrations in healthy adult subjects.

Key facts

Study ID

NCT00983255

Run by

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

People needed

90

Starts

2009-09-01

Expected to finish

2010-01-01

Last updated by the study team

2016-05-19

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 post menopausal 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 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.