NCT03596632已完成1 期
A Phase 1 Open-label Study Investigating the Excretion Balance, Pharmacokinetics, and Metabolism of a Single Oral Dose of [14C/12C]-Labeled Fenebrutinib in Healthy Volunteers
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
- 8
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of the Total Radioactive Dose Administered Excreted from Urine and Feces"; TimeFrame: "Day 1 to end of study (approximately 35 days post-dose)
研究概览
简要总结
The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects, between 18 and 60 years of age, inclusive
- •Within body mass index range 18 to 32 kg/m2, inclusive
- •In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs, and physical examination
- •For males who are sterile: agreement to use a condom with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion; for males who are fertile: agreement to use a condom with spermicide with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion
排除标准
- •History or symptoms of any significant disease
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
- •History of stomach or intestinal surgery or resection, except appendectomy, hernia repair, and cholecystectomy
- •History of malignancy, except for non-melanoma skin carcinoma with 3-year disease-free follow-up
- •Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Day -1
- •Exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1
- •Participation in a radiolabeled drug study in which exposures are known to the Investigator within 4 months prior to Day -1, or participation in a radiolabeled drug study in which exposures are not known to the Investigator within 6 months prior to Day -
- •The total 12-month exposure from this study and a maximum of 2 other studies must be within the Code of Federal Regulations (CFR) recommended levels considered state (per 21 CFR 361.1), e.g. less than 5,000 mrem whole body annual exposure
研究组 & 干预措施
Single Oral Solution Dose
Experimental
Single 200-mg (approximately 100-µCi) oral solution dose of [14C/12C]-fenebrutinib under fasted conditions.
干预措施: Fenebrutinib (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of the Total Radioactive Dose Administered Excreted from Urine and Feces"; TimeFrame: "Day 1 to end of study (approximately 35 days post-dose)
时间窗: Screening to end of study (approximately 35 days post-dose)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any AE that can be fatal, life threatening, prolongs inpatient hospitalization, significant disability, congenital anamoly, is a significant medical event in the Investigator's judgment.
次要结局
- Maximum Observed Concentration (Cmax) of Fenebrutinib and its Metabolites(Day 1 pre-dose to end of study (approximately 35 days post-dose))
- Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of Fenebrutinib and its Metabolites(Day 1 pre-dose to end of study (approximately 35 days post-dose))
- Area under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of Fenebrutinib and its Metabolites(Day 1 pre-dose to end of study (approximately 35 days post-dose))
- Time to Observed Maximum Concentration (Tmax) of Fenebrutinib and its Metabolites(Day 1 pre-dose to end of study (approximately 35 days post-dose))
- Cumulative Percent of Total Radioactivity Excreted in Urine Over the Sampling Interval (Total % Feu)(Day 1 pre-dose to end of study (approximately 35 days post-dose))
- Number of Participants With Clinical Significant Changes in Physical Examination Findings(Day -1, 28)
- Number of Participants With Clinical Significant Changes in Electrocardiograms (ECGs)(Screening, Day-1, 1 (Pre-dose; 1, 3 hours [h] post-dose), 28, 31)
- Cumulative Percent of Total Radioactivity Excreted in Feces Over the Sampling Interval (Total % Fef)(Day 1 pre-dose to end of study (approximately 35 days post-dose))
- Number of Participants With Clinical Significant Changes in Clinical Laboratory Results(Screnning, Day -1, 2, 4, 28)
- Number of Participants With Clinical Significant Changes in Vital Signs(Screening up to Day 31)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Assess the Pharmacokinetics of ASP015K in Healthy Male SubjectsHealthy SubjectsPharmacokinetics of ASP015KNCT01406132Astellas Pharma Inc6
已完成
1 期
A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the BodyAdvanced Solid TumorsPharmacokinetics of 14C-OSI-906NCT01529684Astellas Pharma Global Development, Inc.5
已完成
1 期
A Study of 14C JNJ-67953964 in Healthy Adult Male ParticipantsHealthyNCT05197062Janssen Research & Development, LLC8
终止
1 期
Open-Label Absorption, Distribution, Metabolism, Excretion (ADME) and Pharmacokinetics (PK) Following a Single Oral Dose of AZD1236 in Healthy Male SubjectsHealthyNCT01007929AstraZeneca4
进行中（未招募）
1 期
Single Dose Study To Study The Absorption, Metabolism And Excretion Of FamitinibHealthy SubjectsNCT05473468Jiangsu HengRui Medicine Co., Ltd.6