Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156

BIAL

Status and phase

Completed

Phase 1

Conditions

Parkinson Disease

Treatments

Drug: Carbon-14 BIA 28-6156

Study type

Interventional

Funder types

Industry

Identifiers

NCT05220072

BIA 28-6156-106

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

Male

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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