A Single-Center, Open-Label, Single Oral Dose Phase I Study to Determine the Excretion Balance of Radiocarbon (i.e., the Sum of 14C-Labeled TRO19622 and Its 14C-Metabolites) and to Investigate the Pharmacokinetics and Metabolic Profile of TRO19622
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- CL/F of Radiocarbon
研究概览
简要总结
This Phase I study is designed to determine the excretion balance of radiocarbon, as the sum of carbon-14 (14C)-labeled TRO19622 and its 14C-metabolites, and to investigate the pharmacokinetics and metabolic profile of TRO19622 (olesoxime) in healthy participants.
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
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) 20.0 to 28.0 kilograms per meter-squared (kg/m^2) and body weight at least 60 kilograms (kg)
- •Fitzpatrick skin type less than (<) 4
- •Good health according to medical history, physical examination, laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG)
- •Negative urine test for drugs of abuse
- •Negative alcohol breath test
- •Negative tests for hepatitis or human immunodeficiency virus (HIV)
- •Use of effective contraception during and for 3 months beyond study participant, among sexually active non-vasectomized participants with females partners of childbearing potential
排除标准
- •Concomitant or recent medication use within 2 weeks prior to Day 1, except for paracetamol
- •Use of enzyme-inducing drugs within 2 months prior to Day 1
- •Any medical condition that may alter the pharmacokinetics of olesoxime or affect interpretation of study results
- •Irregular bowel movements
- •Drug addiction or alcoholism
- •Use of nicotine products
- •Participation in another clinical study within 12 weeks prior to Day 1
- •Exposure to ionizing radiation within one year prior to Day 1
研究组 & 干预措施
Olesoxime
Participants will receive a single dose of liquid suspension of 14C-labeled olesoxime containing an equivalent of 600 milligrams (mg) of the compound. The total amount of administered radiocarbon will be 93 microcuries (mcCi), or 3.447 megabecquerels (MBq).
干预措施: Olesoxime (Drug)
结局指标
主要结局
CL/F of Radiocarbon
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
T1/2 of Radiocarbon
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
Apparent Plasma Clearance (CL/F) of Olesoxime and Any Major Metabolite(s) Identified
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
Apparent Volume of Distribution (Vz/F) of Olesoxime and Any Major Metabolite(s) Identified
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
Vz/F of Radiocarbon
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
Cumulative Amount of Olesoxime Excreted in Urine
时间窗: Continuous urine collection from pre-dose (0 h) to post-dose (432 h, or until release criteria are met) following single dose on Day 1
Cumulative Amount of Olesoxime Excreted in Expired Air
时间窗: Pre-dose (0 h) and post-dose (8, 10, 12, 16, 24, 48, 72, 96 h) following single dose on Day 1
Cumulative Amount of Olesoxime Excreted in Feces
时间窗: Continuous fecal collection from pre-dose (0 h) to post-dose (432 h, or until release criteria are met) following single dose on Day 1
Renal Clearance (CLr) of Olesoxime
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
AUClast of Radiocarbon
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
AUCinf of Radiocarbon
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
Percentage of Participants with Adverse Events (AEs)
时间窗: Continuously from Screening until 7 days after last dose (up to 46 days overall)
Maximum Observed Concentration (Cmax) of Olesoxime and Any Major Metabolite(s) Identified
时间窗: Pre-dose (0 hours [h]) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
Cmax of Radiocarbon
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
Time of Maximum Observed Concentration (Tmax) of Olesoxime and Any Major Metabolite(s) Identified
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
Tmax of Radiocarbon
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
Area Under the Concentration-Time Curve from Drug Administration to Last Quantifiable Concentration (AUClast) of Olesoxime and Any Major Metabolite(s) Identified
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Olesoxime and Any Major Metabolite(s) Identified
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
Elimination Half-Life (t1/2) of Olesoxime and Any Major Metabolite(s) Identified
时间窗: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
次要结局
未报告次要终点