Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg

Completed · Phase 1

Conditions studied: Bacterial Infection

In brief

The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.

Key facts

Study ID

NCT01271998

Run by

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

People needed

20

Starts

2010-12-08

Expected to finish

2011-01-03

Last updated by the study team

2019-11-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males and females, between 18 and 55 years of age, inclusive
• Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control
• Males must be surgically sterile, abstinent, or practicing an effective method of birth control
• BMI between 20 and 34.9 kg/m2, inclusive

You may not qualify if…

• Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes
• Physician-diagnosed migraine headaches within 3 years
• Previous enrollment in a TR-701 or TR-701 FA trial

Where it is running

• Trius Investigator Site 001 — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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