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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Collection of plasma samples for metabolite profiling
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Carbon-14 BIA 28-6156
Healthy volunteers receive a single dose of Carbon-14 BIA 28-6156
干预措施: Carbon-14 BIA 28-6156 (Drug)
结局指标
主要结局
Collection of plasma samples for metabolite profiling
时间窗: 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
时间窗: 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)
时间窗: Urine: Day 1 through Day 11, Faeces: Day -1 through Day 11
CumAe and Cum%Ae
Collection of plasma samples for structural identification
时间窗: 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
时间窗: Pre-dose until 240 hours post-dose
Total radioactivity for total recovery of Carbon-14 BIA28-6156
次要结局
- 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)