A Phase I, Two-part, Open-label, Non-randomised Study to Investigate the Mass Balance Recovery and Metabolic Profile of 14C Debio 1450 Following Single Oral and Intravenous Doses in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Routes of metabolism and excretion after a single dose of radiolabelled Debio 1450 measured through total radioactivity concentrations in expired air, urine and fecaes
研究概览
简要总结
The primary objectives of this study are:
- To determine the mass balance recovery (expired air, urine and faeces) and route and rate of elimination of 14C-Debio 1450.
- To determine the metabolic profile of 14C-Debio 1450 in whole blood, plasma, urine and faeces.
- To determine the pharmacokinetics of total radioactivity and of Debio 1450 (prodrug) and Debio 1452 (active moiety) in plasma and urine.
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
- 35 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Meets protocol-specified criteria for qualification and contraception
- •Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
- •Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
排除标准
- •Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- •Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- •the safety or well-being of the participant or study staff
- •the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
- •the analysis of results
研究组 & 干预措施
Part A: Cohort 1
Participants receive a single intravenous (IV) dose of 240 mg/3.7 megabecquerel (MBq) of [14C-pos 1]-Debio 1450 BES solution.
干预措施: [14C-pos 1]-Debio 1450 BES Solution (Drug)
Part A: Cohort 2
Participants receive a single oral dose of 240 mg/3.7 MBq of [14C-pos 1]-Debio 1450 BES solution.
干预措施: [14C-pos 1]-Debio 1450 BES Solution (Drug)
Part B: Cohort 3
Participants receive a single oral dose of 240 mg Debio 1450/37 kilobecquerel (kBq) of [14C-pos 25]-Debio 1450 BES solution.
干预措施: [14C-pos 25]-Debio 1450 BES Solution (Drug)
结局指标
主要结局
Routes of metabolism and excretion after a single dose of radiolabelled Debio 1450 measured through total radioactivity concentrations in expired air, urine and fecaes
时间窗: 168 hours after dosing (Day 8)
Mass balance recovery after a single dose of radiolabelled Debio 1450 measured through total radioactivity excreted in expired air, urine and faeces
时间窗: 168 hours after dosing (Day 8)
Whole blood and plasma partitioning of total radioactivity after a single dose of radiolabelled Debio 1450 through measurement of total radioactivity levels in blood
时间窗: 168 hours after dosing (Day 8)
Blood is collected within the 168 hours as follows: * IV infusion: Predose, 1, 1.85, 2.25, 2.5, 3, 4, 5, 8, 14, 18, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours after the infusion start time * Oral administration: Predose,15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 and 168 hours following the oral dose
Percentage of participants with clinically significant change from baseline in vital signs, electrocardiogram, and/or laboratory parameters
时间窗: 168 hours after dosing (Day 8)
次要结局
未报告次要终点