Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156
- Conditions
- Parkinson Disease
- Interventions
- Drug: Carbon-14 BIA 28-6156
- Registration Number
- NCT05220072
- Lead Sponsor
- Bial R&D Investments, S.A.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Carbon-14 BIA 28-6156 Carbon-14 BIA 28-6156 Healthy volunteers receive a single dose of Carbon-14 BIA 28-6156
- Primary Outcome Measures
Name Time Method Collection of plasma samples for metabolite profiling Pre-dose until 240 hours post-dose Collection of major metabolites for metabolite profiling of BIA28-6156
Collection of urine and faecal samples for total radioactivity Urine and Faeces: Pre-dose until 288 hours post-dose Total radioactivity for total recovery of Carbon-14 BIA28-6156
Mass balance recovery of total radioactivity in all excreta (urine and faeces) Urine: Day 1 through Day 11, Faeces: Day -1 through Day 11 CumAe and Cum%Ae
Collection of plasma samples for structural identification Pre-dose until 240 hours post-dose Identification of chemical structure of major metabolites of BIA28-6156
Collection of whole blood samples for total radioactivity Pre-dose until 240 hours post-dose Total radioactivity for total recovery of Carbon-14 BIA28-6156
- Secondary Outcome Measures
Name Time Method Determination of routes and rates of elimination of Carbon-14 BIA 28-6156 Day 1 through Day 11 Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating plasma total radioactivity and more than 10% of total radioactive dose Urine and Faeces: Day 1 through Day 11, Plasma: Day 1 through Day 7 Measurement of BIA 28-6156 PK parameters Day 1 through Day 11 Evaluation of whole blood: plasma concentration ratios for total radioactivity Day 1 through Day 7 Adverse events (AEs) Screening through Day 11
Trial Locations
- Locations (1)
Quotient Sciences
🇬🇧Ruddington, Nottingham, United Kingdom