An Open-Label,2-Part Sequential Dose Study Designed to Assess the Absolute Bioavailability, Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structure for [14C]-AQX-1125 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Mass balance recovery of total radioactivity in urine, faeces and all excreta
研究概览
简要总结
This study is conducted to evaluate the absolute bioavailability, metabolism and elimination pathways of AQX-1125 in healthy male and female subjects.
详细描述
This is a single-centre, open-label, non-randomised, 2-part, sequential dose study in healthy male and female subjects. It is planned to enrol a single cohort of 8 healthy subjects (4 male and 4 female) who will participate in Part 1 and Part 2 of the study.
In Part 1, each subject will receive a single oral dose of AQX-1125 followed by an IV microtracer dose of carbon-14-AQX-1125 ([14C]-AQX-1125). In Part 2, each subject will receive a single oral dose of [14C]-AQX-1125.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Open-Label
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Healthy females of non-child bearing potential
- •BMI 18.0 to 35 kg/m2
排除标准
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- •Current smokers and those who had smoked within the last 12 months; this included cigarettes, e-cigarettes and nicotine replacement products. Positive cotinine test result at screening and each admission
- •Clinically significant abnormal clinical chemistry, haematology, urinalysis or electrocardiogram (ECG)
研究组 & 干预措施
AQX-1125 Oral Tablet
AQX-1125 - Oral Tablet
干预措施: AQX-1125 Oral Tablet (Drug)
[14C]-AQX-1125 IV
Radiolabelled AQX-1125 - Intravenous
干预措施: [14C]-AQX-1125 IV (Drug)
[14C]-AQX-1125 Oral Solution
Radiolabelled AQX-1125 - Oral Solution
干预措施: [14C]-AQX-1125 Oral Solution (Drug)
结局指标
主要结局
Mass balance recovery of total radioactivity in urine, faeces and all excreta
时间窗: 0 -168 hrs
Cum Ae expressed as a percentage of the administered dose (Cum %Ae)
Measure Cum% Ae (total) for urine and faeces
时间窗: 0-168 hrs
Absolute bioavailability (F) of AQX-1125
时间窗: 0 - 96 hrs
Metabolite profiling and structural identification in plasma, urine and faeces to estimate the routes and rates of elimination of [14-C]-AQX-1125
时间窗: 0 -168 hrs
Measure Ae total radioactivity for urine and faeces
时间窗: 0-168 hrs
Measure %Ae total radioactivity for urine and faeces
时间窗: 0-168 hrs
Measure Cum Ae (total) for urine and faeces
时间窗: 0-168 hrs
Measure PK parameters of total radioactivity in plasma following oral administration
时间窗: 0 -96 hrs
Cmax
Measure PK parameters of total radioactivity in plasma following oral administration:
时间窗: 0 -96 hrs
MRT
次要结局
- Safety and tolerability assessments based on adverse events, safety laboratory tests, vital signs, physical examinations, ECGs and AEs (Part 1)(0 - 96 hrs)
- Chemical structure of major metabolites of [14-C]-AQX-1125(0 -168 hrs)
- PK parameters of AQX-1125 in plasma following IV administration (Part 1)(0 - 96 hrs)
- PK parameters of AQX-1125 in plasma following oral administration (Part 1)(0-96 hrs)
- Measure plasma whole blood concentration ratios for total radioactivity (Part 2)(0 -168 hrs)
- Safety and tolerability assessments based on adverse events, safety laboratory tests, vital signs and ECG (Part 2)(0 -168 hrs)
- PK parameters of AQX-1125 in plasma following oral administration (Part 2)(0 -168 hrs)