Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects

Sponsor

Keith A. Rodvold (Other)

Overall Status

Completed

CT.gov ID

NCT00925392

Collaborator

Pulmonary Associates, PA (Other)

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Doripenem Drug: Doripenem	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Doripenem 500 mg	Drug: Doripenem Intravenous 500 mg every (q) 8 hours for 3 doses Other Names: Doribax
Experimental: Doripenem 1000 mg	Drug: Doripenem Intravenous 1000 mg q 8 hours for 3 doses Other Names: Doribax

Arm

Intervention/Treatment

Experimental: Doripenem 500 mg

Drug: Doripenem

Intravenous 500 mg every (q) 8 hours for 3 doses

Other Names:

Doribax

Experimental: Doripenem 1000 mg

Drug: Doripenem

Intravenous 1000 mg q 8 hours for 3 doses

Other Names:

Doribax

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulmonary Associates, PA	Phoenix	Arizona	United States	85006

Sponsors and Collaborators

Keith A. Rodvold
Pulmonary Associates, PA

Investigators

Principal Investigator: Keith A. Rodvold, Pharm.D., University of Illinois at Chicago
Principal Investigator: Larry H. Danziger, Pharm.D., University of Illinois at Chicago
Principal Investigator: Mark H. Gotfried, M.D., Pulmonary Associates, PA