JPRN-jRCTs031200012已完成未知
OPEN-LABEL, RANDOMIZED, CROSSOVER STUDY TO ASSESS THE DOSE-DEPENDENT EFFECT OF CYCLOSPORIN A ON THE PHARMACOKINETICS OF ENDOGENOUS BIOMARKERS AND PROBE DRUGS FOR ASSESSMENT OF DRUG-DRUG INTERACTIONS MEDIATED BY OATP1B
Furihata Kenichi0 个研究点目标入组 10 人开始时间: 2020年4月13日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
We demonstrated that administration of cyclosporine A which is capable to inhibit OATP1B caused an increase in the plasma concentrations of several endogenous compounds that exceeded DDI risk criteria, and the increment was dose-dependent. CP-I is highly useful as a biomarker for quantitative assessment of OATP1B-mediated DDI risk, considering that (1) its AUCR and CmaxR showed high correlation coefficients with cyclosporine A AUC, and (2) unlike probe drugs, it was not affected by the dosing interval with
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 40age old（—）
- 性别
- Male
入选标准
- •a) Healthy Japanese men at >=20 but <40 years of age when the consent was obtained.
- •b) Persons who were judged appropriate as subjects by the investigator (sub-investigator) based on medical history and physical exam and laboratory tests at screening.
- •c) Persons whose body mass index (BMI) is >=18.5 but <25.0 at screening.
- •d) Subjects who can understand and comply with the protocol and from whom the written consent based on his or her own free will can be obtained.
排除标准
- •a) Persons with a history of hypersensitivity to the probe drugs, and cyclosporin A
- •b) Persons with lactose intolerance
- •c) Persons with hypotension (systolic blood pressure: <90 mmHg) or hypertension (systolic blood pressure: >=160 mmHg)
- •d) Persons who donated or lost 200 mL (1 unit) of blood within 4 weeks before administration of study drugs or 400 mL (2 units) of blood within 3 months before administration of study drugs.
- •e) Persons with a medical history/complication of severe nerve disease, cerebrovascular disease, liver disease, kidney disease, endocrine disease, cardiovascular disease, gastrointestinal disease (including digestive system disease which is considered to affect the absorption of study drugs), respiratory disease, metabolic disease, and anemia.
- •f) Persons diagnosed as Rotor syndrome or Gilbert syndrome
- •g) Persons who have been confirmed of a clinically severe abnormality based on medical examination or physical examination by the investigator or subinvestigator.
- •h) Persons with a clinically severe disease within 30 days before administration of study drugs.
- •i) Persons who took drugs, health food including St. Johns wort, food 14 days prior to dosing and beverages including grapefruit, orange and apple (including food containing them), and nutritional supplements 7 days prior to dosing and cannot comply with prohibition of taking them during the study.
- •j) Persons who are smoking or taking nicotine within 30 days before administration of study drugs and who cannot comply with smoking cessation during the study period.
- •k) Persons who took alcohol/caffeine-containing food on the day before hospitalization in each study period and cannot comply with prohibition of taking them until the day of discharge in each study period.
- •l) Persons who tested positive in an alcohol breathe test/urine drug test at screening.
- •m) Persons who cannot discontinue the use of drugs other than study drugs from 2 weeks before administration of study drugs until the study completion.
- •n) Persons who are positive to hepatitis B surface (HBs) antigens, hepatitis C (HCV) antibodies, or human immunodeficiency virus (HIV) antigens/antibodies.
- •o) Other persons who were judged inappropriate by the investigator or subinvestigator.
研究者
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