A Phase 1, Open Label Study to Characterize the Absorption, Metabolism, and Excretion of 14C JNJ-67953964 After a Single Dose in Healthy Adult Male Participants
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
- Duodenal Concentrations of Aticaprant and its Metabolite M3
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetic (PK), metabolism, and routes of excretion of aticaprant and its metabolites in excreta and in plasma after a single oral dose 14C-aticaprant in healthy adult male 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
- Basic Science
- 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
- •Healthy on the basis of physical examination, medical history (screening only), vital signs, and electrocardiogram (ECG) performed at screening and admission to the study site on Day -
- •Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable
- •Body weight not less than 50 kilograms (kg) and body mass index (BMI; weight [kg]/height^2 [m^2]) within the range of 18.0 to 29.9 kilogram per meter square (kg/m^2) (inclusive)
- •Blood pressure (after the participant is supine for 5 minutes) between 90 millimeters of mercury (mmHg) and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening and Day -1
- •A 12-lead ECG consistent with normal cardiac conduction and function, at screening and Day -1, including: sinus rhythm; pulse rate between 40 and 100 beat per minutes (bpm), extremes included; QTc interval less than or equal to (<=) 450 milliseconds (ms) for men; QRS interval of less than (<) 120 ms; PR interval < 210 ms; morphology consistent with healthy cardiac conduction and function
- •Non-smokers (not smoked for 3 months prior to screening)
排除标准
- •History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin, or malignancy, which is considered cured with minimal risk of recurrence)
- •Known allergies, hypersensitivity, or intolerance to aticaprant or its excipients
- •History of clinically significant (example: in the opinion of the investigator) drug and/or food allergies
- •Participant has presence of left bundle branch block, atrioventricular block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator
- •Anatomical (nasal) abnormalities which may make the placement of the nasoduodenal tube difficult (only for participants with duodenal sampling)
研究组 & 干预措施
14C-aticaprant
Participants in Group A (without duodenal fluid collection) and Group B (with duodenal fluid collection) will receive a single oral dose of 14C-aticaprant on Day 1.
干预措施: 14C-aticaprant (Drug)
结局指标
主要结局
Duodenal Concentrations of Aticaprant and its Metabolite M3
时间窗: Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
Duodenal fluid samples will be analyzed to determine concentrations of aticaprant and its Metabolite M3 using a, specific, and sensitive (LC-MS/MS) method.
Urine Concentration of Aticaprant and its Metabolites M3
时间窗: Pre-dose up to Day 32
Urine samples will be analyzed to determine concentrations of aticaprant and its metabolite M3 using a, specific, and sensitive (LC-MS/MS) method.
Plasma Concentrations of Aticaprant and its Metabolite M3
时间窗: Up to Day 39
Plasma samples will be analyzed to determine concentrations of aticaprant and its Metabolite M3 using a validated, specific, and sensitive liquid chromatography (LC)-mass spectrometry (MS)/MS method.
Total Radioactivity Concentration of 14C-aticaprant in Whole Blood
时间窗: Pre-dose up to Day 14
Total radioactivity concentration of 14C-aticaprant in whole blood will be performed via liquid scintillation counting.
Total Radioactivity Concentration of 14C-aticaprant in Plasma
时间窗: Pre-dose up to Day 14
Total radioactivity concentration of 14C-aticaprant in plasma will be performed via liquid scintillation counting.
Total Radioactivity Concentration of 14C-aticaprant in Duodenal Fluid
时间窗: Pre-dose, 3.75 hour, 4 hour and 5 hour of Day 1
Total radioactivity concentration of 14C-aticaprant in duodenal fluid samples will be performed via liquid scintillation counting.
Amount of Total Radioactivity of 14C-aticaprant in Urine
时间窗: Up to Day 32
Amount of total radioactivity of 14C-aticaprant in urine will be performed via liquid scintillation counting.
Amount of Total Radioactivity of 14C-aticaprant in Feces
时间窗: Up to Day 32
Amount of total radioactivity of 14C-aticaprant in feces will be performed via liquid scintillation counting.
次要结局
- Number of Participants with Physical Examination Abnormalities(Up to Day 67)
- Number of Participants with Clinical Laboratory Abnormalities(Up to Day 67)
- Number of Participants with Electrocardiogram (ECG) Abnormalities(Up to Day 67)
- Number of Participants with Adverse Events (AEs)(Up to Day 67)
- Number of Participants with Vital Signs Abnormalities(Up to Day 67)