A Phase I, Open-Label, Single Dose ADME Study of 14C-ACH-0144471 in Healthy Male Subjects
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
- Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Maximum Observed Concentration (Cmax)
研究概览
简要总结
This was an open-label study to evaluate the absorption, distribution, metabolism, and excretion of radioactivity in healthy male participants following a single 150-milligram (mg) oral dose of carbon-14 ([14C])-ACH-014447 ([14C])-danicopan) containing approximately 100 microcuries (µCi) of [14C].
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 was defined as having no clinical relevant abnormalities identified by a detailed medical history, physical exam, blood pressure and pulse rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
- •Body mass index of ≥ 18 and ≤ 30 kilograms (kg)/meter squared and weight of ≥ 50 kg and ≤ 100 kg.
- •Regular daily bowel movements (that is, production of at least 1 stool per day).
- •Non-smoker or ex-smoker who had not used tobacco or nicotine products for ≥ 3 months prior to screening.
排除标准
- •History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- •History of conditions or procedures possibly affecting drug absorption or excretion. A history of appendectomy, cholecystectomy, and hernia repair was allowed if they were not associated with complications.
- •Active bacterial infection or clinically significant active viral infection, a body temperature > 38°Celcius, or other evidence of infection on Day 1, or with a history of febrile illness within 7 days prior to Day
- •Healthy participants who had been exposed to significant radiation levels of > 5 millisieverts in the last year prior to screening.
- •Clinically significant laboratory abnormalities at screening or Day -1, as well as absolute neutrophil counts, platelets, and hemoglobin outside of reference ranges.
研究组 & 干预措施
[14C]-Danicopan
Participants were administered a single oral dose of danicopan between 151 and 154 mg (nominal dose of 150 mg), providing approximately 100 μCi of [14C] radiolabel in the form of [14C]-danicopan.
干预措施: [14C]-Danicopan (Drug)
结局指标
主要结局
Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Maximum Observed Concentration (Cmax)
时间窗: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Mean Cumulative Percentages Of Total Radioactivity Recovered In Urine And Feces Following A Single Oral Dose Of [14C]-Danicopan
时间窗: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Time To Maximum Observed Concentration (Tmax)
时间窗: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-t
时间窗: Up to 96 hours postdose
Whole Blood And Plasma Pharmacokinetics (PK) Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Area Under The Concentration-time Curve From Time 0 To The Time Of Last Quantifiable Concentration (AUC0-t)
时间窗: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Whole Blood And Plasma PK Of Total Radioactivity After A Single Oral Dose Of [14C]-Danicopan: Area Under The Concentration-time Curve Extrapolated to Infinity (AUC0-inf)
时间窗: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Cmax
时间窗: Up to 96 hours postdose
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: Tmax
时间窗: Up to 96 hours postdose
[14C]-Danicopan Metabolites In Plasma, Urine, And Feces
时间窗: Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period
Plasma PK Of Danicopan After A Single Oral Dose Of [14C]-Danicopan: AUC0-inf
时间窗: Up to 96 hours postdose
次要结局
- Percentage Of Total Radioactivity Detected For Each [14C]-Danicopan Metabolite in Plasma, Urine, And Feces(Up to 96 hours postdose or maximum of 216 hours postdose for extended collection period)
- Incidence Of Treatment-emergent Adverse Events(Day 1 through Day 10)