ISRCTN51111674进行中（未招募）1 期
A phase I, open-label, single-centre study to evaluate the absorption, distribution, metabolism and excretion (ADME) of oral [14C]-ibrexafungerp in healthy male subjects after repeat dosing
Scynexis (United States)0 个研究点目标入组 6 人开始时间: 2022年12月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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. 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 defined in the protocol
- •5. Healthy males
- •6. Body mass index (BMI) of 18.0 kg/m2 to 30.0 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. 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, haematological or GI disease, neurological or psychiatric disorder,
- •irritable bowel syndrome, gastritis, intermittent vomitus or diarrhoea as judged by the investigator
- •4. Influenza or a viral infection within the 30 days prior to first IMP administration
- •5. Acute diarrhoea or constipation in the 7 days before the predicted first study day. If screening occurs >7 days before admission, this criterion will be determined admission/pre-first dose. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day
- •6. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
- •7. Evidence of current SARS-CoV-2 infection
- •8. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are not allowed
- •9. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or HIV 1 and 2 antibody results
- •10. Subjects with ALT or AST or bilirubin values >ULN at screening
- •11. Haemoglobin or platelet count values 12. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation
- •13. 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
- •14. Subjects who report to have previously received ibrexafungerp, including in SCY-078-116 (QSC202765)
- •15. 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
- •16. Subjects who have been administered IMP in an ADME study in the last 12 months
- •17. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- •18. 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 first IMP administration on Day 1 (see Section 11.4). Vaccines are not accepted concomitant medications. 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 jeopardise the safety of the trial subject; and if the use of medication is not cons
研究者
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