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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation; Drug Interactions

Treatments: Drug: Rifampin; Drug: Voriconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02576366

TacDDI151010

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male
• Age over 18 years
• Written informed consent

Exclusion criteria

• Female
• Medical comorbidities
• Use of concomitant medication

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Voriconazole

Experimental group

Description:

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.

Treatment:

Drug: Voriconazole

Rifampin

Experimental group

Description:

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

Treatment:

Drug: Rifampin