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 range
30 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To Determine the Mass Balance Recovery After a Single Oral Dose of [14C]-Rencofilstat
. 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