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Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT00925392
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : March 14, 2013
Sponsor:
Collaborator:
Pulmonary Associates, PA
Information provided by (Responsible Party):
Keith A. Rodvold, University of Illinois at Chicago

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 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 Type : Interventional  (Clinical Trial)
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 : June 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Doripenem
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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. [ Time Frame: 32 hours ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 24 hours post end of doripenem administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925392


Locations
United States, Arizona
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

Responsible Party: Keith A. Rodvold, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00925392     History of Changes
Other Study ID Numbers: DORICPK4002
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013

Keywords provided by Keith A. Rodvold, University of Illinois at Chicago:
doripenem
epithelial lining fluid
alveolar macrophages
pharmacokinetics
Healthy adult subjects