NCT00925392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 14, 2013

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

June 17, 2009

Last Update Submit

March 12, 2013

Conditions

Healthy

Keywords

doripenemepithelial lining fluidalveolar macrophagespharmacokineticsHealthy adult subjects

Outcome Measures

Primary Outcomes (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.

    32 hours

Secondary Outcomes (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.

    24 hours post end of doripenem administration

Study Arms (2)

Doripenem 500 mg

EXPERIMENTAL
Drug: Doripenem

Doripenem 1000 mg

EXPERIMENTAL
Drug: Doripenem

Interventions

DoripenemDRUG

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

Also known as: Doribax
Doripenem 500 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Associates, PA

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Interventions

Doripenem

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 22, 2009

Study Start

June 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 14, 2013

Record last verified: 2013-03

Locations

US(1)