An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of Carbon-14 BIA 28-6156 in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- Carbon-14 BIA 28-6156
- Conditions
- Parkinson Disease
- Sponsor
- Bial R&D Investments, S.A.
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Collection of plasma samples for metabolite profiling
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
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.
Arms & Interventions
Carbon-14 BIA 28-6156
Healthy volunteers receive a single dose of Carbon-14 BIA 28-6156
Intervention: Carbon-14 BIA 28-6156
Outcomes
Primary Outcomes
Collection of plasma samples for metabolite profiling
Time Frame: 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
Time Frame: 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)
Time Frame: Urine: Day 1 through Day 11, Faeces: Day -1 through Day 11
CumAe and Cum%Ae
Collection of plasma samples for structural identification
Time Frame: 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
Time Frame: Pre-dose until 240 hours post-dose
Total radioactivity for total recovery of Carbon-14 BIA28-6156
Secondary Outcomes
- 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)