A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Praliciguat ([14C]-IW-1973) Following a Single Oral Dose in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Apparent volume of distribution of praliciguat (Vz/F)
研究概览
简要总结
The primary objective is to characterize the pharmacokinetics (PK) of praliciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of [14C]-praliciguat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males of any race, between 18 and 55 years of age, inclusive
- •Body mass index between 18 and 32 kg/m2, inclusive
- •Subject is in good health and has no clinically significant findings on physical examination
- •Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 90 days after the final dose of study drug
排除标准
- •Any active or unstable clinically significant medical condition
- •Use of any prescribed or non-prescribed medication
- •Additional inclusion/exclusion criteria may apply per protocol
研究组 & 干预措施
Healthy Male Volunteers
Single oral dose of [14C]-praliciguat
干预措施: [14C]-praliciguat (Drug)
结局指标
主要结局
Apparent volume of distribution of praliciguat (Vz/F)
时间窗: up to Day 15
Amount of total radioactivity excreted in urine (Aeu) and feces (Aef)
时间窗: up to Day 15
Percentage of total radioactivity in total excreta (feces + urine)
时间窗: up to Day 15
AUC0-last of total radioactivity in plasma and whole blood
时间窗: up to Day 15
Maximum observed concentration (Cmax) of praliciguat in plasma
时间窗: up to Day 15
Cmax of total radioactivity in plasma and whole blood
时间窗: up to Day 15
AUC0-inf of whole blood total radioactivity to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Blood Total Radioactivity/Plasma Total Radioactivity)
时间窗: up to Day 15
Cumulative Aeu and cumulative Aef
时间窗: up to Day 15
Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of praliciguat in plasma
时间窗: up to Day 15
AUC0-inf of total radioactivity in plasma and whole blood
时间窗: up to Day 15
AUC from time zero to the last quantifiable concentration (AUC0-last) of praliciguat in plasma
时间窗: up to Day 15
t1/2 total radioactivity in plasma and whole blood
时间窗: up to Day 15
Apparent total clearance of praliciguat (CL/F)
时间窗: up to Day 15
Percentage of total radioactivity excreted in urine (feu) and feces (fef)
时间窗: up to Day 15
Cumulative feu and cumulative fef
时间窗: up to Day 15
Time of Cmax (Tmax) of praliciguat in plasma
时间窗: up to Day 15
Tmax of total radioactivity in plasma and whole blood
时间窗: up to Day 15
Apparent terminal elimination half-life (t1/2) of praliciguat in plasma
时间窗: up to Day 15
AUC0-inf of plasma praliciguat concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Plasma Praliciguat/Plasma Total Radioactivity)
时间窗: up to Day 15
次要结局
- Chromatographic retention time of metabolites(up to Day 15)
- Number(s) of participants with ≥1 treatment-emergent serious adverse event (SAE)(up to Day 15)
- Characteristic mass spectrometry fragmentation ions of metabolites(up to Day 15)
- Levels of metabolite radioactivity excreted in urine and feces(up to Day 15)
- Molecular ion mass of metabolites(up to Day 15)
- AUC0-inf of metabolite radioactivity levels in plasma(up to Day 15)
- AUC0-inf of plasma metabolite radioactivity levels relative to AUC0-inf of plasma total radioactivity (Plasma AUC0-inf Ratio of Metabolite Radioactivity/Total Radioactivity)(up to Day 15)
- Chemical structures (graphical representations showing atom connectivity) proposed for plasma, urine, and feces metabolites(up to Day 15)
- Number(s) of participants with ≥1 adverse event (AE) leading to study drug discontinuation(up to Day 15)
- Number(s) of participants with ≥1 Grade ≥3 AE (per CTCAE v. 5.0)(up to Day 15)
- Number(s) of participants with ≥1 clinically significant abnormal physical examination finding(up to Day 15)