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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2017

Interventions

  • Drug: Voriconazole
  • Drug: Rifampin

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Change in tacrolimus area under the curve
    • Time Frame: 2 weeks
    • assessed twice: once after each treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Male – Age over 18 years – Written informed consent Exclusion Criteria:

  • Female – Medical comorbidities – Use of concomitant medication

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen KU Leuven
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dirk RJ Kuypers, MD, PhD, Principal Investigator, Universitaire Ziekenhuizen KU Leuven

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.