Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects (NCT05737433) | Clinical Trial Compass
CompletedEarly Phase 1
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
United Kingdom6 participantsStarted 2023-03-01
Plain-language summary
This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat (\[14C\] CRV431). It is planned to enroll 6 healthy male subjects in a single group. Each subject will receive a single 225 mg oral dose of \[14C\] CRV431 self-micro emulsifying drug delivery system (SMEDDS) oral emulsion.
Who can participate
Age range30 Years – 65 Years
SexMALE
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Inclusion criteria
✓. Healthy males
✓. Aged 30 to 65 years inclusive at the time of signing informed consent
✓. Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening
✓. Must be willing and able to communicate and participate in the whole study
✓. Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
✓. Must provide written informed consent
✓. Must agree to adhere to the contraception requirements
Exclusion criteria
✕. 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)
What they're measuring
1
To Determine the Mass Balance Recovery After a Single Oral Dose of [14C]-Rencofilstat