NCT05737433 - Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects | Syfrah

Trials Sponsors Conditions Drugs Pricing

You may not qualify if:

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
Subjects who are, or are immediate family members of, a study site or sponsor employee
Evidence or history of current SARS-CoV-2 infection within 4 weeks prior to study drug administration
History of any drug or alcohol abuse in the past 2 years prior to screening
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)
A confirmed positive alcohol breath test at screening or admission
Current smokers and those who have smoked within the last 12 months prior to screening
A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to screening
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
Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening
Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects known to have Gilbert's syndrome are excluded
Confirmed positive drugs of abuse test result
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
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
+7 more criteria