mass balance recovery and metabolite identification of carbon-14 bia 28-6156

Conditions: Parkinson Disease

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.

this is an open-label, single-dose, single period study in healthy male subjects. it is planned to enroll 6 subjects. all subjects will receive a single oral dose carbon-14 bia 28-6156. blood samples will be collected at regular intervals for pk analysis, mass balance and metabolite profiling and identification from pre-dose up to 240 h post-dose. urine and faecal samples will be collected at regular intervals for mass balance and metabolite profiling and identification from pre-dose until the mass balance criteria have been met.

Eligibility criteria:
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. * 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 creatinine clearance (clcr) of \<80 ml/min using the cockcroft-gault equation * history of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder * serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients * presence or history of clinically significant allergy requiring treatment. hay fever is allowed unless it is active * donation of blood or plasma within the previous 3 months or loss of greater than 400 ml of blood * subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before imp administration. * failure to satisfy the investigator of fitness to participate for any other reason