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
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