Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects

This study has been completed.
Sponsor:
Collaborator:
Pulmonary Associates, PA
Information provided by (Responsible Party):
Keith A. Rodvold, University of Illinois
ClinicalTrials.gov Identifier:
NCT00925392
First received: June 17, 2009
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Healthy
Drug: Doripenem
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

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. [ Time Frame: 32 hours ] [ Designated as safety issue: No ]

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. [ Time Frame: 24 hours post end of doripenem administration ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: June 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Keith A. Rodvold, Professor, University of Illinois
ClinicalTrials.gov Identifier: NCT00925392     History of Changes
Other Study ID Numbers: DORICPK4002
Study First Received: June 17, 2009
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Illinois at Chicago:
doripenem
epithelial lining fluid
alveolar macrophages
pharmacokinetics
Healthy adult subjects

ClinicalTrials.gov processed this record on April 16, 2014