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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02576366

Enrollment

Registered

2015-10-15

Start date

2016-06-30

Completion date

2017-12-31

Last updated

2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Interactions, Kidney Transplantation

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.

Interventions

DRUGVoriconazole

DRUGRifampin

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Male * Age over 18 years * Written informed consent

Exclusion criteria

* Female * Medical comorbidities * Use of concomitant medication

Design outcomes

Primary

Measure	Time frame	Description
Change in tacrolimus area under the curve	2 weeks	assessed twice: once after each treatment

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026