ISRCTN21667877已完成1 期
An open-label, single period, multiple-dose study designed to assess the mass balance, metabolite profile and metabolite identification of [14C]-SPN-817 in healthy male subjects
Supernus Pharmaceuticals (United States)0 个研究点目标入组 8 人开始时间: 2022年7月12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 64 years inclusive at the time of signing informed consent
- •3. Body mass index (BMI) of 18.0 to 32.0 kg/m² as measured at screening
- •4. Must be willing and able to communicate and participate in the whole study
- •5. Must have regular bowel movements (ie average stool production of =1 and =3 stools per day)
- •6. Must provide written informed consent
- •7. 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. Subjects who have previously been administered IMP in this study
- •4. Evidence of current SARS-CoV-2 infection
- •5. History of any drug or alcohol abuse in the past 2 years
- •6. Regular alcohol consumption >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)
- •7. A confirmed positive alcohol breath test at screening or admission
- •8. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- •9. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •10. Male subjects with pregnant or lactating partners
- •11. 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
- •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 not 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 CLcr of <80 mL/min using the Cockcroft-Gault 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. Resting heart rate <50 bpm at screening
- •19. History of bladder outflow obstruction such as benign prostatic hyperplasia or any history of acute urinary retention
- •20. Creatine kinase =1.5 x upper limit of normal
- •21. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •22. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •23. Donation of blood or plasma within the previous 3 months or loss of greater than 400 ml of blood
- •24. Subjects who are taking, or have taken, any prescribed or over-the-counter drug, or herbal remedies or vaccines, including the COVID-19 vaccine, (other than up to 4 g of paracetamol per day) in the 14 days before IMP administration. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a sho
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