Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

This study is being performed to measure the amount of the antibiotic doripenem (study drug) found in the fluid and cells of the lung and blood after receiving three doses of doripenem. The major objectives of this research are to see how much and for how long doripenem gets into the fluids and cells of the lungs of healthy adult subjects.

Key facts

Study ID

NCT00925392

Run by

Keith A. Rodvold

People needed

40

Starts

2009-06-01

Expected to finish

2010-01-01

Last updated by the study team

2013-03-14

Who can join

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

You may qualify if…

• Healthy men and women at least 18 years of age who have no history of smoking within the last 1 year.
• Subjects must be healthy with no clinically important abnormalities in the medical history, physical examination, or laboratory values.

You may not qualify if…

• Subjects must not have a history of allergic or other serious reactions to doripenem or any beta-lactam antibiotic, benzodiazepines or lidocaine.

Where it is running

• Pulmonary Associates, PA — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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