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OpenTrials
Completed

NCT Number: NCT02576366

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • Age over 18 years
  • Written informed consent

Exclusion criteria

  • Female
  • Medical comorbidities
  • Use of concomitant medication

Treatment and study plan

Voriconazole

Drug

Other names: Vfend

Rifampin

Drug

Other names: Rifadin; Rifadine

Primary outcomes

  1. Change in tacrolimus area under the curve

    Time frame: 2 weeks

    assessed twice: once after each treatment

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2015
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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