ISRCTN74587134已完成1 期
A phase 1 study to investigate the absorption, distribution, metabolism, and excretion of [14C] S 033188 following oral dose administration in healthy adult male subjects
Shionogi Ltd0 个研究点目标入组 6 人开始时间: 2016年10月5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
- 6
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
- 性别
- Male
入选标准
- •1. Male subjects who are able to understand the study and comply with all study procedures, and willing to provide written informed consent before screening
- •2. Male subjects aged from 30 years to 65 years inclusive at the time of signing informed consent
- •3. Male subjects who are considered healthy by the investigator (or subinvestigator) based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs measurements and ECG. If any clinical abnormality is identified and/or a laboratory test value exceeds the site's standard value, subjects will be considered appropriate for the study only if the investigator judges the abnormality to be not clinically significant and not to increase the risk to the subject by participation in the study nor to compromise study endpoints
- •4. Male subjects whose body weight is = 50 kg and body mass index (BMI) is = 18.0 to = 32.0 kg/m2
- •5. Male subjects must agree to use appropriate contraception methods from the admission day (Day -1) until 3 months after discharge and agree not to donate sperm during this period
排除标准
- •1. Subjects who regularly have < 1 bowel movement every 2 days
- •2. Subjects who have abnormal bowel habits such as diarrhoea, loose stools, or constipation within 2 weeks prior to the screening visit or prior to Day -1
- •3. Female subjects
- •4. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionizing Radiation Regulations 1999, shall participate in the study
- •5. Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator at screening
- •6. Subjects with a history of any diseases of metabolism, liver, kidney, blood, lung, heart, stomach and intestines, urinary organs, endocrine system, nervous system, and mental illness, who have been judged to be ineligible for participation in this study by the investigator (or subinvestigator)
- •7. Subjects who need constant medication or have used any medication (including non-prescription drugs, vitamins, and dietary or herbal supplements) within 14 days before admission; exceptions may be permitted on a case by case basis if considered not to interfere with the aims of the study and agreed by the investigator and sponsor’s medical advisor
- •8. Subjects who have received strong CYP inducers (rifampicin, carbamazepine, phenytoin, enzalutamide, mitotane, and St John’s wort) and/or P-gp inducers (rifampicin, carbamazepine, phenytoin, tipranavir/ritonavir, and St John’s wort) within 28 days before admission
- •9. Subjects with the following laboratory abnormalities at screening:
- •9.1. Total bilirubin >1.2 × upper limit of normal (ULN)
- •9.2. Alanine aminotransferase (ALT) > 1.2 × ULN
- •9.3. Aspartate aminotransferase (AST) > 1.2 × ULN
- •9.4. Creatinine clearance < 60 mL/min/1.73m2
- •10. Subjects who have QTcF interval of > 450 msec at screening
- •11. Subjects whose resting systolic pressure is outside the range of 90-140 mmHg (aged 30-45 years) or 90-160 mmHg (aged 46 to 65 years), resting diastolic pressure is outside the range of 40-90 mmHg, or a pulse rate is outside the range of 40-90 beats per minute at screening
- •12. Subjects with a history of surgical resection of the stomach, vagus nerve, intestines, etc (excluding appendectomy)
- •13. Subjects with a history of clinically significant allergic symptoms, including food allergies (excluding allergic rhinitis presenting no symptoms at the time of screening)
- •14. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •15. Subjects who have a history or regular use of tobacco- or nicotine-containing products within 6 months before screening
- •16. Subjects with a history of drug and/or alcohol addiction within the past 2 years before screening or a positive test for drugs or alcohol at screening or admission visit
- •17. Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- •18. Subjects with a positive result on any of the tests for the serologic detection of HI
研究者
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