Overview

Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects

Status:
Completed

Trial end date:
2010-01-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Keith A. Rodvold

Collaborator:

Pulmonary Associates, PA

Treatments:

Doripenem

Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

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