Status:
COMPLETED
Mass Balance Recovery and Metabolite Identification of Carbon-14 BIA 28-6156
Lead Sponsor:
Bial R&D Investments, S.A.
Conditions:
Parkinson Disease
Eligibility:
MALE
30-65 years
Phase:
PHASE1
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05220072
Start Date
August 28 2021
End Date
October 16 2021
Last Update
May 28 2025
Active Locations (1)
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1
Quotient Sciences
Ruddington, Nottingham, United Kingdom, NG11 6JS