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Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT02576366
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
18
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Single center, open label crossover study with 2 treatment phases in healthy volunteers.

The potential of phenotypic drug probes to predict drug-drug interactions between tacrolimus, voriconazole and rifampin will be assessed.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Voriconazole

Four hundred mg of voriconazole (2 tablets of 200 mg Vfend; Pfizer, Karlsruhe, Germany) will be administered twice daily on day 2. Two hundred mg of voriconazole (1 tablet of 200 mg Vfend) will be administered twice daily on days 3, 4, 5 and 6.

Drug: Voriconazole
Other Names:
  • Vfend

    		•
    Experimental: Rifampin

    Six hundred mg of rifampicin (2 tablets of 300mg Rifadine; Sanofi, Belgium) will be administered once daily on days 7 through 13.

    Drug: Rifampin
    Other Names:
  • Rifadin; Rifadine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in tacrolimus area under the curve [2 weeks]

      assessed twice: once after each treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Male

    • Age over 18 years

    • Written informed consent

    Exclusion Criteria:

    • Female

    • Medical comorbidities

    • Use of concomitant medication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Leuven Leuven Vlaams-Brabant Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    • Principal Investigator: Dirk RJ Kuypers, MD, PhD, Universitaire Ziekenhuizen Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT02576366
    Other Study ID Numbers:
    • TacDDI151010
    First Posted:
    Oct 15, 2015
    Last Update Posted:
    Aug 22, 2019
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:
    Rifampin
    Voriconazole

    Study Results

    No Results Posted as of Aug 22, 2019