Effect of food on the pharmacokinetics ofonce-daily prolonged-release tacrolimus
- Conditions
- Interaction between food and tacrolimus.Healthy volunteers
- Registration Number
- DRKS00012830
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 37
• Male or female Caucasian.
• Age 18 to < 65 years.
• BMI 18-30 kg/m2 and body weight >= 40 kg.
• Good state of health (physically and mentally) as determined by medical assessment consisting of a medical history, physical examination, an ECG, and a laboratory evaluation that all show no clinically relevant abnormalities.
• Known CYP3A5 genotype or participation in genotyping study.
• No clinically relevant findings in any of the investigations of the SCR visit.
• Agreement to abstain from St. John’s wort (Hypericum perforatum L.) during the time of the trial.
• Agreement to follow specified dietary requirements (e.g. some citrus products, especially grapefruit, are not allowed).
•Agreement to follow specified, highly effective contraceptive measures.
• Able to communicate well with the investigator, to understand and comply with the requirements of the trial.
• Voluntarily signed informed consent after full explanation of the trial to the participant.
• Intake of a substance known to induce or inhibit drug metabolizing enzymes or drug transporters within a period of less than 10 times the respective elimination half-life or two weeks, whatever is longer (except oral contraceptives or levothyroxine).
• Any physical disorder that could interfere with the participant’s safety during the clinical trial or with the trial objectives.
• Any acute or chronic illness or clinically relevant finding in the pre-trial examination known or expected to modify absorption, distribution, metabolism, or excretion of the drug under investigation.
• QTcF > 440 ms (males) or > 460 ms (females).
• Regular smoking.
• Excessive alcohol drinking (more than approximately 20 g/d alcohol).
• Any participation in an interventional clinical trial within the last 4 weeks before inclusion.
• Blood donation within 4 weeks (males) or 8 weeks (females) before the first trial day (refers to whole blood or red blood cell donation; plasma and/or platelet donation are considered acceptable).
• Pregnancy or lactation.
• Known intolerance to tacrolimus, midazolam, or further ingredients.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in tacrolimus exposition (AUC0-inf) due to food. Comparison after administration of two different tacrolimus preparations (Envarsus® and Prograf®).<br>(AUC0-inf = area under the curve, extrapolated to infinity).
- Secondary Outcome Measures
Name Time Method Factors that may be associated with the individual degree of the drug-drug interaction (e.g. CYP3A phenotype, rs776746 polymorphism).