ISRCTN51059297已完成1 期
Open-label study to investigate pharmacokinetics, mass balance and metabolite profiles of NRD135S.E1 in healthy adult male volunteers
ovaremed AG (Switzerland)0 个研究点目标入组 8 人开始时间: 2022年3月9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
- 8
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. Healthy males
- •2. Aged 30 to 65 years inclusive at the time of signing informed consent
- •3. Body mass index (BMI) of =18.0 kg/m² and <30.0 kg/m² as measured at screening
- •4. Must be willing and able to communicate and participate in the whole study
- •5. Must be willing to consume the drug formulation that contains a small amount of alcohol
- •6. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day )
- •7. Must provide written informed consent
- •8. Must agree to adhere to the contraception requirements defined in the clinical protocol
排除标准
- •1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
- •2. Subjects who are, or are immediate family members of, a study site or sponsor employee
- •3. Evidence of current SARS-CoV-2 infection within 2 weeks of first IMP administration or current ongoing symptoms from previous SARS-CoV-2 infection
- •4. History of any drug or alcohol abuse in the past 2 years
- •5. Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- •6. A confirmed positive alcohol breath test at screening or admission
- •7. Current smokers and those who have smoked within the last 6 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- •8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •9. Male subjects with pregnant or lactating partners
- •10. 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 Ionising Radiation Regulations 2017, shall participate in the study
- •11. Subjects who have been administered IMP in an ADME study in the last 12 months prior to screening
- •12. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •13. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed
- •14. Confirmed positive drugs of abuse test result
- •15. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
- •16. Evidence of renal impairment at screening, as indicated by an estimated eGFR of <60 mL/min using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation
- •17. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- •18. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •19. Subjects with history of intolerance to alcohol
- •20. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •21. Donation of blood or plasma or loss of greater than 400 mL of blood within the previous 3 months
- •22. Subjects with a haemoglobin lower than the lower limit of normal at screening
- •23. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before NRD135S.E1 administration. Exceptions may apply on a case by case basis, if considered not to interf
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