- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02576366
Phenotypic Drug Probes as Predictors of Drug-drug Interactions With Tacrolimus
August 21, 2019 updated by: Universitaire Ziekenhuizen KU Leuven
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- University Hospitals Leuven
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- Age over 18 years
- Written informed consent
Exclusion Criteria:
- Female
- Medical comorbidities
- Use of concomitant medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Other Names:
|
Experimental: Rifampin
Six hundred mg of rifampicin (2 tablets of 300mg Rifadine; Sanofi, Belgium) will be administered once daily on days 7 through 13.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in tacrolimus area under the curve
Time Frame: 2 weeks
|
assessed twice: once after each treatment
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dirk RJ Kuypers, MD, PhD, Universitaire Ziekenhuizen KU Leuven
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
October 12, 2015
First Submitted That Met QC Criteria
October 12, 2015
First Posted (Estimate)
October 15, 2015
Study Record Updates
Last Update Posted (Actual)
August 22, 2019
Last Update Submitted That Met QC Criteria
August 21, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Leprostatic Agents
- Hormone Antagonists
- Cytochrome P-450 Enzyme Inducers
- Antifungal Agents
- Steroid Synthesis Inhibitors
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- 14-alpha Demethylase Inhibitors
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Rifampin
- Voriconazole
Other Study ID Numbers
- TacDDI151010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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