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Assessment of Target Site Pharmacokinetics of Voriconazole in Healthy Volunteers During Sequence Therapy

NCT01539330 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2013-11-01

No results posted yet for this study

Summary

The present study aims at measuring unbound voriconazole concentrations in plasma and at the relevant target site of systemic fungal infections, i.e. the interstitial space fluid of soft tissues, to assess the target site pharmacokinetics. For this purpose the microdialysis technique will be employed which is capable of measuring the unbound, microbiologically active concentration of antifungals in the interstitial space fluid of virtually all tissues. This is the first human study of this drug employing the microdialysis technique determining the target site concentrations over several days (single and multiple dosing).

Conditions

  • Healthy

Interventions

DRUG

Voriconazole

At beginning of study visit 1 (0-12 h): 6 mg/kg, IV (in the vein) over a period of 120 min at beginning of study visit 2 (12-24 h): 6 mg/kg, IV (in the vein) over a period of 120 min at beginning of study visit 3 (24-36 h): 4 mg/kg, IV (in the vein) over a period of 80 min at beginning of study visit 4 (36-48 h): 4 mg/kg, IV (in the vein) over a period of 80 min at beginning of study visit 5 (48-60 h), 6 (60-72 h) and 7 (72-84 h): 200 mg po

OTHER

microdialysis

long-term microdialysis over study days 1-4 (visits 1-7)

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • Martin-Luther-Universität Halle-Wittenberg

    lead OTHER

Principal Investigators

  • Markus Müller, Prof. Dr. · Medical University of Vienna, Department of Clinical Pharmacology

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2013-02-28
Completion
2013-08-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01539330 on ClinicalTrials.gov