NCT02576366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

October 12, 2015

Last Update Submit

August 21, 2019

Conditions

Drug InteractionsKidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Change in tacrolimus area under the curve

    assessed twice: once after each treatment

    2 weeks

Study Arms (2)

Voriconazole

EXPERIMENTAL

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.

Drug: Voriconazole

Rifampin

EXPERIMENTAL

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

Drug: Rifampin

Interventions

VoriconazoleDRUG
Also known as: Vfend
Voriconazole
RifampinDRUG
Also known as: Rifadin; Rifadine
Rifampin

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Age over 18 years
  • Written informed consent

You may not qualify if:

  • Female
  • Medical comorbidities
  • Use of concomitant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Interventions

VoriconazoleRifampin

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Dirk RJ Kuypers, MD, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2015

First Posted

October 15, 2015

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

August 22, 2019

Record last verified: 2019-08

Locations

BE(1)