DRKS00032072已完成1 期
Assessment of the influence of the gut microbiome on tacrolimus pharmacokinetics in healthy volunteers - TacroBiom
niversitätsklinikum Heidelberg, Im Wege der Auftragsverwaltung für die Universität Heidelberg, Medizinische Fakultät Heidelberg0 个研究点目标入组 20 人开始时间: 2023年8月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 59 Years（—）
- 性别
- All
入选标准
- •Written, personally signed and dated informed consent to participate in the trial prior to any trial-related interventions.
- •Understanding, ability, and willingness to fully comply with trial interventions and restrictions.
- •Body weight = 45 kg.
- •Willingness to use a highly effective method of contraception.
- •CYP3A5*3/*3 genotype.
- •Agreement to follow specified dietary requirements.
- •Willingness to adhere to rules and restrictions necessary to ensure adequate bowel cleansing.
- •Willingness to adhere to pandemic regulations if any may occur during the trial.
排除标准
- •Clinically significant or relevant abnormalities as assessed by the investigator in the medical history, or findings from physical examination, or laboratory evaluation.
- •Any acute or chronic illness expected to influence the volunteer´s gut microbiome composition.
- •Intake of antibiotics (p.o. or i.v.) in the six weeks prior to expected first IMP administration.
- •Any acute or chronic illness or clinically relevant finding known or expected to modify absorption, distribution, metabolism, or excretion of tacrolimus or midazolam.
- •Any known history of severe anaphylactic reactions to drugs or vaccinations, or any other significant allergies.
- •Any known allergies to the trial drugs, to other macrolides, or further ingredients of the administered IMPs.
- •Glucose-6-phosphate dehydrogenase deficiency.
- •QTcF > 440 ms (males) or > 460 ms (females).
- •Use of an IMP within 30 d prior to the expected date of receiving the first dose of IMP or active enrolment in another drug or vaccine clinical trial.
- •Regular use of any medication (prescription medication, non-prescription medication including herbal preparations) with active ingredients (except hormonal contraception, iodine, and thyroid hormones).
- •Any systemically relevant intake of substances known to induce relevant drug metabolizing enzymes or drug transporters within a period of less than 14 d with regard to the expected date of the first dose of tacrolimus and midazolam.
- •Any systemically relevant intake of substances known to inhibit relevant drug metabolizing enzymes or transport enzymes within a period of less than 5 times the respective elimination half-life with regard to the expected date of first dose of tacrolimus and midazolam.
- •Consumption of grapefruit within 7 d prior to the expected date of first dose of IMP and expected noncompliance to refrain from grapefruit intake until the last visit of this trial.
- •A prior vaccination within < 2 weeks (< 4 weeks in case of live-attenuated vaccines) before the first IMP administration or any plans to get vaccinated during the running trial.
- •Expected noncompliance to refrain from alcohol 24 h before the PK days, or pathologic alcohol consumption.
- •Unable to refrain from smoking during trial days.
- •A positive human immunodeficiency virus (HIV) or hepatitis C (HCV) antibody screen, or positive result for Hepatitis-B-Surface-Antigen.
- •A positive result in the drug screening test at SCR.
- •Pregnancy or breast feeding.
- •Persons who are held in an institution by legal or official order or who are legally incapacitated.
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