Phase I, Open Label, Single Dose Study to Determine the Pharmacokinetics, Metabolism, and Excretion of [14C]-Evobrutinib in Healthy Participants
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
- Renal Clearance of Evobrutinib, Total Radioactivity and its Metabolites
研究概览
简要总结
The purpose of the study is to determine the absorption, metabolism, and excretion of [14C]-evobrutinib 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
- Other
- 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
- •Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
- •Have a body weight within 50.0 to 120.0 kilogram (kg) (inclusive) and body mass index within the range 19.0 - 30.0 kilogram per meter square (kg/m^2) (inclusive)
- •Male participants agree to be consistent with local regulations on contraception methods
- •Can give signed informed consent
- •Other protocol defined inclusion criteria could apply
排除标准
- •History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
- •Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery
- •Any surgical or medical condition which might significantly alter the ADME of drugs
- •History of any malignancy, chronic or recurrent acute infection
- •History of shingles
- •History of drug hypersensitivity ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients
- •History of alcoholism or drug abuse
- •History of residential exposure to tuberculosis, or a positive QuantiFERON test at screening
- •Administration of live vaccines or live-attenuated virus vaccines
- •Any condition, including findings in the laboratory tests, medical history, or other screening assessments, that in the opinion of the Investigator constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study's objectives, conduct, or evaluation
- •Prior/concomitant therapy
- •Relevant radiation exposure
- •Clinically relevant findings (excluding minor deviations) in biochemistry, hematology, coagulation and urinalysis
- •Vital signs (pulse rate and blood pressure) outside the normal range
- •Estimated Glomerular Filtration rate according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
- •Semi supine systolic blood pressure (SBP) greater than (>) 140 millimeters of Mercury (mmHg) or less than (<) 90 mmHg, diastolic blood pressure (DBP) > 90 mmHg or < 45 mmHg and pulse rate >= 100 bpm or =< 40 bpm, at admission
- •12-Lead electrocardiogram (ECG) showing a QTcF > 450 millisecond (ms), PR > 215 ms, or QRS > 120 ms
- •Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) I and II tests at screening
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Evobrutinib
干预措施: Evobrutinib (Drug)
结局指标
主要结局
Renal Clearance of Evobrutinib, Total Radioactivity and its Metabolites
时间窗: Pre-dose up to Day 35 post-dose
Maximum Observed Plasma Concentration (Cmax) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
时间窗: Pre-dose up to Day 35 post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
时间窗: Pre-dose up to Day 35 post-dose
Terminal Elimination Half-Life (t1/2) of Evobrutinib
时间窗: Pre-dose up to Day 35 post-dose
Total Radioactivity Recovery Rate of Evobrutinib, Total Radioactivity and its Metabolites
时间窗: Pre-dose up to Day 35 post-dose
Percentage Excretion of Evobrutinib, Total Radioactivity and its Metabolites in Urine and Feces
时间窗: Pre-dose up to Day 35 post-dose
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib
时间窗: Pre-dose up to Day 35 post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Evobrutinib
时间窗: Pre-dose up to Day 35 post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Evobrutinib
时间窗: Pre-dose up to Day 35 post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/f) of Evobrutinib
时间窗: Pre-dose up to Day 35 post-dose
Apparent Clearance (CL/f) of Evobrutinib
时间窗: Pre-dose up to Day 35 post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
时间窗: Pre-dose up to Day 35 post-dose
Terminal Elimination Half-Life (t1/2) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
时间窗: Pre-dose up to Day 35 post-dose
次要结局
- Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings(From time of first dose to end of study participation approximately at Day 37)
- Occurrence of Treatment -emergent Adverse Events (TEAEs) and Serious TEAEs(From time of first dose to end of study participation approximately at Day 37)
- Occurrence of Treatment -emergent Adverse Events (TEAEs) and Serious TEAEs by Severity(From time of first dose to end of study participation approximately at Day 37)