Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers Dori_MD_1

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: doripenem

• Registration Number: NCT01311141
• Lead Sponsor: Medical University of Vienna

Brief Summary

In the present study we will measure and compare the unbound, i.e. microbiologically active concentrations of doripenem after a single dose of 500mg in plasma, subcutaneous adipose tissue and muscle tissue and saliva of healthy volunteers. We will use the microdialysis technique, which allows for the continuous measurement of unbound drug concentrations in the interstitial space fluid. The findings of the present study will help to assess whether currently employed therapy regimens with doripenem provide effective antimicrobial concentrations in different compartments in man

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-08
• Study Start: 2010-08
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-09
• Last Update Submitted: 2011-03-31
• Last Update Posted: 2011-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Healthy
• Male

Exclusion Criteria

• Female
• Ill

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Doripenem i.v.	doripenem	no comparator, PK study

Primary Outcome Measures

Name	Time	Method
The time versus unbound doripenem concentration profiles in the interstitial space fluid of non inflamed subcutaneous adipose tissue, muscle tissue, saliva and plasma

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria