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

NCT ID: NCT02576366

Last Updated: 2019-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Drug Interactions Kidney Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Voriconazole

Intervention Type DRUG

Rifampin

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

Group Type EXPERIMENTAL

Rifampin

Intervention Type DRUG

Interventions

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Voriconazole

Intervention Type DRUG

Rifampin

Intervention Type DRUG

Other Intervention Names

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Vfend Rifadin; Rifadine

Eligibility Criteria

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Inclusion Criteria

* Male
* Age over 18 years
* Written informed consent

Exclusion Criteria

* Female
* Medical comorbidities
* Use of concomitant medication
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk RJ Kuypers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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TacDDI151010

Identifier Type: -

Identifier Source: org_study_id

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