Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus
Phase 4
Completed
- Conditions
- Drug InteractionsKidney Transplantation
- Interventions
- Registration Number
- NCT02576366
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Male
- Age over 18 years
- Written informed consent
Exclusion Criteria
- Female
- Medical comorbidities
- Use of concomitant medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Voriconazole 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. Rifampin Rifampin Six hundred mg of rifampicin (2 tablets of 300mg Rifadine; Sanofi, Belgium) will be administered once daily on days 7 through 13.
- Primary Outcome Measures
Name Time Method Change in tacrolimus area under the curve 2 weeks assessed twice: once after each treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospitals Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium