ISRCTN57533271已完成1 期
An open-label, single-dose study designed to assess the mass balance recovery, metabolite profile and identification of [14C]-REN001 in healthy male subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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. Healthy males
- •2. Aged 30 to 65 years, inclusive, at the time of signing informed consent
- •3. Body mass index (BMI) of 18.0 to 30.0 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 (i.e. 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 within 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 report to have previously received REN001
- •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 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)
- •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. 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 have been administered IMP in an ADME study in the last 12 months
- •13. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •14. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are not allowed.
- •15. Confirmed positive drugs of abuse test result
- •16. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- •17. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation
- •18. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- •19. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •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 within the previous 3 months or loss of greater than 400 mL of blood
- •22. 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 IMP administration). Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardize the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study. COVID-19 vaccines are accepted concomitant medications.
- •23. Failure to satisfy the investigator of fitness to participate for any other reason
研究者
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