Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156 (NCT05220072) | Clinical Trial Compass
CompletedPhase 1
Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156
United Kingdom6 participantsStarted 2021-08-28
Plain-language summary
The study is designed to determine the absorption, distribution, metabolism and elimination (ADME) of BIA 28-6156 in humans, further explore the PK of BIA 28-6156, evaluate the extent of distribution of total radioactivity into blood cells, provide additional safety and tolerability information and collect samples for metabolite profiling and structural identification.
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
* Body mass index (BMI) of 18.0 to 35.0 kg/m2
* Must be willing and able to communicate and participate in the whole study
* Must have regular bowel movements
* Must provide written informed consent
* Must agree to adhere to contraception requirements
Exclusion Criteria:
* Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
* Subjects who are, or are immediate family members of, a study site or sponsor employee
* Evidence of current SARS-CoV-2 infection from results of diagnostic tests or from symptoms reported at screening or admission
* History of any drug or alcohol abuse in the past 2 years
* Regular alcohol consumption
* A confirmed positive alcohol breath test at screening or admission
* Current smokers and those who have smoked within the last 12 months.
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
* Subjects with pregnant or lactating partners
* 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.
* Subjects who do not have suitable veins for multiple venepunctures/cannulation
* Clinically significant abnormal clinical chemistry, haematology or urinalysis. Subjects with Gilbert's Syndrome are allowed.
* Con…
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
Mass balance recovery of total radioactivity in all excreta (urine and faeces)
Timeframe: Urine: Day 1 through Day 11, Faeces: Day -1 through Day 11
2
Collection of urine and faecal samples for total radioactivity
Timeframe: Urine and Faeces: Pre-dose until 288 hours post-dose
3
Collection of plasma samples for metabolite profiling
Timeframe: Pre-dose until 240 hours post-dose
4
Collection of plasma samples for structural identification
Timeframe: Pre-dose until 240 hours post-dose
5
Collection of whole blood samples for total radioactivity