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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576366
• Other study ID #: TacDDI151010
• Status: Completed
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male

• Age over 18 years

• Written informed consent

Exclusion Criteria:

• Female

• Medical comorbidities

• Use of concomitant medication

Related Conditions & MeSH terms

• Drug Interactions
• Kidney Transplantation

Intervention

Drug:
• Voriconazole

• Rifampin

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

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