Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Doripenem

• Registration Number: NCT00925392
• Lead Sponsor: Keith A. Rodvold

Brief 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.

Detailed Description

The primary objective of this descriptive study is to determine and compare the plasma, epithelial lining fluid (ELF), and alveolar macrophages (AM) concentrations following multiple intravenous doses of doripenem in healthy, non-smoking adult subjects. In brief, each subject who qualifies for the study will be randomized to one of two dosing regimens: doripenem 500 mg or doripenem 1000 mg every 8 hours for a total of three intravenous doses. Each dose of doripenem will be administered as an intravenous infusion over 4 hours. Serial blood samples for determining plasma doripenem concentrations will be collected prior to and after the start of the intravenous infusion of the third doripenem dose. Each subject will undergo one standardized bronchoscopy with BAL in the outpatient bronchoscopy suite at one of four sampling times after the start of the intravenous infusion of the third doripenem dose. BAL collection will provide samples to determine drug concentration in ELF and AM. Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory tests, and vital sign monitoring.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-12
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Doripenem 500 mg	Doripenem	-
Doripenem 1000 mg	Doripenem	-

Primary Outcome Measures

Name	Time	Method
The primary objective is to determine and compare the plasma, epithelial lining fluid, and alveolar macrophages concentrations following multiple intravenous doses of doripenem in healthy, non-smoking adult subjects.	32 hours

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this study is the assessment of safety and tolerability of doripenem as measured by the overall incidence of treatment-emergent adverse events.	24 hours post end of doripenem administration

Trial Locations

Locations (1)

Pulmonary Associates, PA; 🇺🇸 Phoenix, Arizona, United States