Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX… (NCT03964558) | Clinical Trial Compass
CompletedPhase 1
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430)
United Kingdom6 participantsStarted 2019-04-01
Plain-language summary
This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enroll and dose 6 subjects. Subjects will be admitted to the clinical unit on the evening of Day 1 prior to investigational medicinal product (IMP) administration. Subjects will be dosed on the morning of Day 1 and it is planned that they will remain resident in the clinic until up to 168 hour after dosing (up to Day 8). It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of \>90% or if \<1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 hour periods.
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:
• Body mass index of 18.0 to 35.0 kg/m2
Exclusion Criteria:
* Regular alcohol consumption \>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)
* Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at 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
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.
1This trial used a radioactive version of acebilustat called [14C]-CTX-4430 to track how the drug moves through and exits the body — can you explain what those findings might mean for how safe or predictable this drug could be in patients with actual disease?
2Since this was a Phase 1 study done only in healthy volunteers and it's now completed, what has been learned from it that would inform whether acebilustat is being tested further in people with my condition?
3The trial focused on measuring how much of the radioactive drug was recovered through urine, stool, and other waste — does that data tell us anything about how well the kidneys or liver handle this drug, and whether that matters for someone with my health profile?
4Because this study was purely about how the body processes the drug rather than whether it works as a treatment, are there later-phase trials of acebilustat that are actually testing effectiveness that might be worth discussing as an option?
5Given that this trial involved a single dose of a radioactive compound given to healthy people, what would my doctor need to know about my own health history before considering whether any future acebilustat trials could be appropriate for me to discuss?
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
Mass balance recovery of total radioactivity in all excreta: amount excreted (Ae) and Ae as a percentage of the administered dose (%Ae), cumulative recovery (CumAe), and cumulative recovery expressed as a percentage of the administered dose (Cum%Ae)