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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT01311141
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 7
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: doripenem	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers - a Pilot Study
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Doripenem i.v. no comparator, PK study	Drug: doripenem; doripenem once i.v.500mg

Outcome Measures

Primary Outcome Measures

1. The time versus unbound doripenem concentration profiles in the interstitial space fluid of non inflamed subcutaneous adipose tissue, muscle tissue, saliva and plasma []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy

• Male

Exclusion Criteria:

• Female

• Ill

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01311141
• Other Study ID Numbers: 2010-020778-41
• First Posted: Mar 9, 2011
• Last Update Posted: Apr 1, 2011
• Last Verified: Aug 1, 2010

• Additional relevant MeSH terms: Doripenem

Study Results

No Results Posted as of Apr 1, 2011