Assessment of the effect of drug formulation on the extent of the pharmacokinetic interaction between voriconazole and tacrolimus. - TacroVori

niversität Heidelberg, Medizinische Fakultät0 个研究点目标入组 18 人开始时间: 2017年3月9日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Male Caucasian
•18 to <65 years
•BMI 18-30 kg/m2 and body weight >= 40 kg.
•Good state of health (physically and mentally).
•Known CYP2C19 and CYP3A5 genotype or participation in genotyping study (K093).
•No clinically relevant findings in any of the investigations of the screening 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. citrus products, especially grapefruit are not allowed) starting one week before each trial day.
•Agreement to follow specified 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.
•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, especially any condition known or expected to modify absorption, distribution, metabolism, or excretion of the drug under investigation.
•CYP2C19 poor metaboliser genotype.
•QTcF > 440 ms.
•Regular smoking.
•Excessive alcohol drinking (more than approximately 20 g/d alcohol).
•Any participation in an interventional clinical trial within the last month before inclusion.
•Blood donation within 8 weeks before the first trial day.
•Haemoglobin < 11 g/dl.
•Known intolerance to tacrolimus, midazolam, voriconazole, or further ingredients of the administered brands.

发起方

niversität Heidelberg, Medizinische Fakultät