A Multiple Ascending Dose Study To Assess Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of ACH-0144471 In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), AEs Leading To Discontinuation, And Clinically Significant Laboratory Abnormalities And Electrocardiogram Abnormalities
研究概览
简要总结
This was a multiple ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (75 milligrams [mg], 200 mg, 500 mg, 800 mg) and dose-matched placebo were administered under fasted conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical exam, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
- •Body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
排除标准
- •History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- •Any condition possibly affecting drug absorption (including gastrectomy and cholecystectomy).
- •Body temperature greater than or equal to 38°Celcius on Day -1 or Day 1, Hour 0; history of febrile illness or other evidence of infection within 14 days prior to first study drug administration.
- •Current tobacco/nicotine user; consumption of any alcohol within 72 hours before first study drug administration or have a history of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening; positive urine drug screen at screening or Day -
- •Clinically significant laboratory abnormalities at either Screening or Day -1.
研究组 & 干预措施
Cohort 1: 200 mg
All participants under fasted conditions received 200 mg of danicopan or placebo twice daily (BID) over a 14-day period.
干预措施: Danicopan (Drug)
Cohort 1: 200 mg
All participants under fasted conditions received 200 mg of danicopan or placebo twice daily (BID) over a 14-day period.
干预措施: Placebo (Drug)
Cohort 2: 500 mg
All participants under fasted conditions received 500 mg of danicopan or placebo BID over a 14-day period.
干预措施: Danicopan (Drug)
Cohort 2: 500 mg
All participants under fasted conditions received 500 mg of danicopan or placebo BID over a 14-day period.
干预措施: Placebo (Drug)
Cohort 3: 800 mg
All participants under fasted conditions received 800 mg of danicopan or placebo BID over a 14-day period.
干预措施: Danicopan (Drug)
Cohort 3: 800 mg
All participants under fasted conditions received 800 mg of danicopan or placebo BID over a 14-day period.
干预措施: Placebo (Drug)
Cohort 4: 75 mg
All participants under fasted conditions received 75 mg of danicopan or placebo thrice daily (TID) over a 7-day period.
干预措施: Danicopan (Drug)
Cohort 4: 75 mg
All participants under fasted conditions received 75 mg of danicopan or placebo thrice daily (TID) over a 7-day period.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), AEs Leading To Discontinuation, And Clinically Significant Laboratory Abnormalities And Electrocardiogram Abnormalities
时间窗: Day 1 through Day 42
次要结局
- Maximum Observed Plasma Concentration (Cmax) Of Danicopan(Up to 16 hours postdose)
- Time To Maximum Observed Plasma Concentration (Tmax) Of Danicopan(Up to 16 hours postdose)
- Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Danicopan(Up to 16 hours postdose)
- Activity Of Danicopan As Measured By Alternative Pathway (AP) Wieslab Assay(Up to 16 hours postdose)
- Relationship Between AP Inhibition And Danicopan Plasma Concentrations(Up to 16 hours postdose)