NCT03886103已完成1 期
Pharmacokinetics and Metabolism of [14C]-Labelled PXL770 Following a Single Oral Administration in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Poxel SA
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Mass balance recovery
研究概览
简要总结
This is a single-dose, single center, single-period, open-label, non-randomized, mass balance recovery study in healthy male subjects.
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 Caucasian males
- •Age 30 to 65 years
- •BMI 18.5 to 32.0 kg/m2 and body weight of 55 to 95 kg.
- •Must be willing and able to communicate and participate in the whole study
- •Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day)
- •Must provide written informed consent
- •Regular alcohol consumption of 4-14 units of alcohol per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- •Must agree to adhere to the contraception
排除标准
- •Subjects who have received any IMP in a clinical research study within the previous 3 months or 90 days prior to Day 1
- •any drug or alcohol abuse
- •Current smokers and those who have smoked within the last 12 months.
- •Radiation exposure, including that from the present study, excluding background adiation 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.
- •No occupationally exposedworker, as defined in the Ionizing Radiation Regulations 2017, shall participate in the study
- •Clinically significant abnormal biochemistry, hematology, coagulation or urinalysis as judged by the investigator
- •Positive test for HIV, HBV, HBC
- •eGFR <80 mL/min
- •History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator
- •Known sensitivity to any of the constituents or excipients of the study drug or history of relevant drug and/or food allergy (anaphylactic, anaphylactoid reactions)
- •History of drug-induced Torsade de Pointe or presence of a familial long QT syndrome
- •Mental handicap
研究组 & 干预措施
Healthy volunteer
Experimental
Single of 14C-PXL770
干预措施: 14C labeled PXL770 (Drug)
结局指标
主要结局
Mass balance recovery
时间窗: From day 1 to day 7
Mass balance recovery of total radioactivity in all excreta: cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
次要结局
- PK profile of PXL770(From day 1 to day 7)
- PK profile of total radioactivity(From day 1 to day 7)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](From day 1 to day 7)
研究者
研究点 (1)
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