Target Site Pharmacokinetics of Doripenem After a Single... | NCT01311141

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

NCT01311141

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Apr 1, 2011Estimated

Enrollment

6Estimated

Phase

Phase 4

Conditions

Healthy

Interventions

doripenem

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Mar 8, 2011

First Submission Date that Met QC Criteria

Mar 8, 2011

First Posted Date

Mar 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2011

Last Update Posted Date

Apr 1, 2011Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Doripenem i.v.	Experimental	no comparator, PK study	Drug: doripenem

Interventions

Name	Type	Description	Arm Group Labels	Other Names
doripenem	Drug	doripenem once i.v.500mg	Doripenem i.v.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy
Male

Exclusion Criteria:

Female
Ill

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		1090	Austria

Intervention Browse Module

MeSH Terms

ID	Term
D000077726	Doripenem

Ancestor Terms

ID	Term
D015780	Carbapenems
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

Browse Leaves

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Browse Branches

Not provided