A Two-Part Open-Label, Single-Centre Mass Balance, Pharmacokinetics, Biotransformation and Absolute Bioavailability Study of ODM-201 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Amount of 14C-ODM-201 dose excreted and cumulative amount excreted in urine and faeces and total. Amount excreted and cumulative amount excreted in urine, faeces and total expressed as a percentage of the administered dose.
研究概览
简要总结
A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance and routes of excretion of ODM-201 in healthy volunteers.
详细描述
6 healthy male subjects will be enrolled in part 1 and part 2 of the study, respectively
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 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 50 to 65 years (inclusive)
- •Normal weight defined as a body mass index (BMI) of >18.5 and <32.0 kg/m2
- •Weight 55 to 100 kg (inclusive)
- •Adequate method of contraception during the study and for a period of 6 months after study drug administration
- •Key exclusion Criteria:
- •Evidence of clinically significant disease
- •Intake of any medication that could affect the outcome of the study
- •Known hypersensitivity to the active substances or the excipients of the drug or any serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •History of anaphylactic/anaphylactoid reactions
- •Clinically significant abnormal biochemistry, haematology or urinalysis
- •Current or history of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- •Current use or use within the last 12 months of nicotine products
- •Positive drugs of abuse test result
- •Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results
- •Presence or history of clinically significant allergy requiring treatment
排除标准
- 未提供
研究组 & 干预措施
Part 1
A single oral 300 mg tablet of ODM-201 followed by single intravenous 100 microg of 14C-ODM-201 containing not more than 37 kBq (1000 nCi)14C
干预措施: ODM-201 300 mg tablet (Drug)
Part 1
A single oral 300 mg tablet of ODM-201 followed by single intravenous 100 microg of 14C-ODM-201 containing not more than 37 kBq (1000 nCi)14C
干预措施: intravenous14C-ODM-201 (Drug)
Part 2
A single oral solution of 300 mg 14C-ODM-201 containing no more than 6.3 MBq (171 microCi) 14C
干预措施: 300 mg 14C-ODM-201 oral solution (Drug)
结局指标
主要结局
Amount of 14C-ODM-201 dose excreted and cumulative amount excreted in urine and faeces and total. Amount excreted and cumulative amount excreted in urine, faeces and total expressed as a percentage of the administered dose.
时间窗: Urine and faecal samples are collected baseline (Day-1) 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing
次要结局
未报告次要终点