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

Launched by BIAL R&D INVESTMENTS, S.A. · Jan 25, 2022

Keywords

ClinConnect Summary

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.

Gender

MALE

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