Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects

Exclusion Criteria

• •1. Subjects who have received any investigational treatment 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 or history of current SARS-CoV-2 infection within 4 weeks prior to study drug administration
• •4. History of any drug or alcohol abuse in the past 2 years prior to screening
• •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 12 months prior to screening
• •8. 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 prior to screening
• •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 do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening
• •12. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects known to have Gilbert's syndrome are excluded
• •13. Confirmed positive drugs of abuse test result
• •14. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
• •15. Evidence of renal impairment at screening, as indicated by an estimated eGFR of \<60 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration equation
• •16. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, malabsorptive, neurological or psychiatric disorder, as judged by the investigator
• •17. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• •18. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
• •19. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
• •20. Subjects who have taken known strong or moderate CYP3A4 inducers in the 30 days before IMP administration
• •21. 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 study drug 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 study drug; 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
• •22. Subjects who have had a COVID-19 vaccine 7 days before dosing