NCT05384977已完成1 期
An Open-label, Single Dose, Mass Balance Study to Assess the Disposition of [14C]-NV-5138 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Cumulative total radioactivity in urine and faeces
研究概览
简要总结
The objective of this study is to assess the mass balance and routes of excretion of total radioactivity after a single oral dose of 1600 mg [14C]-NV-5138.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males aged 40 to 65 years inclusive at the time of signing informed consent.
- •Body mass index of 18.0 to 32.0 kg/m2 as measured at screening.
排除标准
- •Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- •Subjects who are, or are immediate family members of, a study site or sponsor employee
- •Evidence of current SARS-CoV-2 infection
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption of >21 units per week and (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)
- •A confirmed positive alcohol breath test at screening or admission
- •Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- •Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •Subjects with pregnant or lactating partners
- •Radiation exposure, including that from the present study, excluding background radiation 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 exposed worker shall participate in the study
- •Subjects who have participated in an ADME study involving carbon-14 within 12 months of screening.
- •Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed
- •Clinically significant abnormalities on vital signs or ECGs as judged by the investigator at screening or pre-dose
- •Confirmed positive drugs of abuse test result
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
- •Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation
- •History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease or neurological disorder, as judged by the investigator
- •Any history of major depression disorder (MDD) requiring treatment or counselling or any other clinically significant psychiatric history, as judged by the investigator
- •Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- •Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- •Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days or 5 half-lives, whichever is longer, before IMP administration. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.
- •Subject answers "yes" to "Suicidal Ideation" Items 1 or 2 on the C-SSRS at screening
- •Failure to satisfy the investigator of fitness to participate for any other reason.
研究组 & 干预措施
[14C]-NV-5138
Experimental
[14C]-NV-5138 oral solution
干预措施: [14C]-NV-5138 (Drug)
结局指标
主要结局
Cumulative total radioactivity in urine and faeces
时间窗: urine and fecal samples up to 168 hours post dose
The percentage of the radioactive dose recovered in urine, faeces and in total
次要结局
- Tlast for NV-5138, metabolite M8 and total radioactivity in plasma whole blood(up to 168 hours post-dose)
- Vz/F for NV-5138 in plasma(up to 168 hours post-dose)
- Whole blood to plasma partitioning for total radioactivity(up to 168 hours post-dose)
- AUCinf for NV-5138, metabolite M8 and total radioactivity in plasma whole blood(up to 168 hours post-dose)
- Tmax for NV-5138, metabolite M8 and total radioactivity in plasma whole blood(up to 168 hours post-dose)
- Cmax for NV-5138, metabolite M8 and total radioactivity in plasma whole blood(up to 168 hours post-dose)
- AUClast for NV-5138, metabolite M8 and total radioactivity in plasma whole blood(up to 168 hours post-dose)
- t1/2 for NV-5138 and total radioactivity in plasma and whole blood(up to 168 hours post-dose)
- CL/F for NV-5138 in plasma(up to 168 hours post-dose)
- MPR Cmax in plasma(up to 168 hours post-dose)
- MPR AUCinf in plasma(up to 168 hours post-dose)
- CLR for NV-5138(up to 168 hours post-dose)
- %Dose for total radioactivity in urine and feces(up to 168 hours post-dose)
- Characterization of metabolites in plasma, urine and fecal homogenates(up to 168 hours post-dose)
- Ae for total radioactivity in urine and feces(up to 168 hours post-dose)
研究者
研究点 (1)
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