ISRCTN16794199已完成1 期
An open label, single-dose, single-period study designed to assess the pharmacokinetics and mass balance recovery, metabolite profile and metabolite identification of ([Cyclohexane-U-14C]-MBS2320) 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. Must provide written informed consent
- •2. Must be willing and able to communicate and participate in the whole study
- •3. Aged 30 to 65 years inclusive at the time of signing informed consent
- •4. Must agree to adhere to the contraception requirements
- •5. Healthy males
- •6. Body mass index (BMI) of 18.0 to 35.0 kg/m² as measured at screening
- •7. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day)
排除标准
- •1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- •2. History of any allergy to sulphonamides. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or GI, neurological or psychiatric disorder, as judged by the investigator
- •4. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •5. Evidence of current SARS-CoV-2 infection or history of contact with an individual known to have COVID-19 infection in the 14 days prior to IMP administration.
- •6. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are allowed. Subjects with white cell count, lymphocyte count or neutrophil count less than the lower limit of normal
- •7. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- •8. Evidence of renal impairment at screening, as indicated by an estimated CLcr of <80 mL/min using the Cockcroft-Gault equation)
- •9. 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
- •10. Subjects who report to have previously received MBS2320
- •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. Donation of blood or plasma or loss of greater than 400 mL of blood within the previous 3 months
- •13. 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 PD activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if
- •the use of medication is not considered to interfere with the objectives of the study
- •14. Subjects who have had any COVID-19 vaccines within 72 h before admission
- •15. History of any drug or alcohol abuse in the past 2 years
- •16. 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)
- •17. A confirmed positive alcohol breath test at screening or admission
- •18. 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
- •19. Current users of e-cigarettes and nicot
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