JPRN-jRCT2080222758未知1 期
An Open-label, Phase 1, Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of TAK-272 and the Effect of TAK-272 on the Pharmacokinetics of Digoxin and Midazolam in the Healthy Adult Subjects
TAKEDA PHARMACEUTICAL COMPANY LTD.0 个研究点目标入组 34 人开始时间: 2015年2月17日最近更新:
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 35age old（—）
- 性别
- Male
入选标准
- •1.In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- •2.The participant who can sign and date the informed consent form before the initiation of the study procedure.
- •3.Healthy Japanese adult male volunteer.
- •4.The participant whois 20 to 35 years of age at the time of informed consent
- •5.The participant who weighs 50 kg or more with a body mass index (BMI) of 18.5 to less than 25.0 kg/m2 at the screening test.
- •6.A male participant who is nonsterilized and sexually active with a female partner of childbearing potential and who agrees to use adequate contraception from the signing of informed consent to 12 weeks after the last dose of erythromycin.
排除标准
- •1.The participant who was administered any investigational product within 16 weeks (112 days) prior to the initial drug administration.
- •2.The participant who has received TAK-272 in previous.
- •3.Employees of the study site, their family members, those who are in a dependency relationsip with employees of the study site involved in the conduct of the study (e.g., spouse, parents, children, brothers and sisters), or those who might be coerced to consent to participate in the study.
- •4.The participant who has poorly controlled, clinically significant abnormalities of the nervous system, cardiovascular system, lungs, liver, kidneys, metabolism, gastrointestinal system, urinary system, endocrinological system or other organs or systems, and which may possibly affect study participation or study results.
- •5.The participant who has a history of serious hepatic disease.
- •6.The participant who has atrioventricular block or sinoatrial block.
- •7.The participant with digitalis intoxication.
- •8.The participant with acute narrow-angle glaucoma.
- •9.The participant with myasthenia gravis.
- •10.The participant with hypersensitivity to TAK-272 or any other renin inhibitors.
- •11.The participant with hypersensitivity to itraconazole, digoxin, digitalis preparation, or midazolam.
- •12.The participant with allergy to cherries.
- •13.The participant with a positive to urine test for drug abuse at the screening.
- •14.The participant with a history of drug abuse (defined as illegal drug use) or alcohol addiction within 1 year prior to the screening visit, and those who are not willing to give up alcohol or drugs during the study period.
- •15.The participant who needs to use prohibited concomitant drugs,vitamins, or foods listed in the table of prohibited concomitant drugs and foods, and the participant who has used any of them during the period prohibiting the concomitant use.
- •16.Male participants who plans to donate sperm during the study period or up to 12 weeks after the end of the study.
- •17.The participant who currently has cardiovascular, central nervous, hepatic, or hematopoietic disease, renal insufficiency, metabolic or endocrinological disorder, serious allergy, asthma, hypoxemia, hypertension, convulsions, or allergic rash.
- •18.The participant with a disease history, examination findings, or clinical test findings related to safety that reasonably suggest a disease for which TAK 272 or related renin inhibitors in the same class, itraconazole, digoxin, or midazolam is contraindicated or a disease that may affect the study conduct (which includes, for example, peptic ulcer disease, convulsive disorder, and arrhythmia).
- •19.The participant who curently has or recently had (within the past 6 months) gastrointestinal disease that may affect drug absorption (malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [at least once a week] heartburn, surgical intervension [e.g., cholecystectomy]).
- •20.The participant with a past history of cancer.
- •21.The participant who is postive for any of the following at screening: hepatitis B virus surface antigen (HBs), antibody against hepatitis C virus (HCV), human immunodeficiency virus (HIV) antigen, anti-HIV antibody, or serological tests for syphilis.
- •22.The participant with difficulty having blood collected from a peripheral vein.
- •23.The participant who donated 200 mL or more whole blood within the 4 weeks (28 days) or 400 mL or more whole blood within the 12 weeks (84 days) before starting the study drug a
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