A Single Ascending Dose Study To Assess The 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
- 44
- 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 single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (200 milligrams [mg], 600 mg, 1200 mg, 2400 mg) and dose-matched placebo were administered under fasted and fed 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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse 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 (for example, gastrectomy), cholecystectomy to be considered acceptable.
- •Body temperature ≥ 38°Celcius on Day -1 or Day 1 Hour 0; history of febrile illness or other evidence of infection within 14 days prior to study drug administration.
- •Current tobacco/nicotine users; consumption of any alcohol within 72 hours before study drug administration or 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
Group 2: 600 mg
All participants (fasted) received either 600 mg of danicopan as a single oral dose or dose-matched placebo.
干预措施: Placebo (Drug)
Group 1: 200 mg
All participants (fasted) received either 200 mg of danicopan as a single oral dose or dose-matched placebo.
干预措施: Danicopan (Drug)
Group 1: 200 mg
All participants (fasted) received either 200 mg of danicopan as a single oral dose or dose-matched placebo.
干预措施: Placebo (Drug)
Group 2: 600 mg
All participants (fasted) received either 600 mg of danicopan as a single oral dose or dose-matched placebo.
干预措施: Danicopan (Drug)
Group 3: 1200 mg
All participants (fasted) received either 1200 mg of danicopan as a single oral dose or dose-matched placebo.
干预措施: Danicopan (Drug)
Group 3: 1200 mg
All participants (fasted) received either 1200 mg of danicopan as a single oral dose or dose-matched placebo.
干预措施: Placebo (Drug)
Group 4: 2400 mg
All participants (fasted) received either 2400 mg of danicopan administered as 2 single doses of 1200 mg each, 12 hours apart, or dose-matched placebo.
干预措施: Danicopan (Drug)
Group 4: 2400 mg
All participants (fasted) received either 2400 mg of danicopan administered as 2 single doses of 1200 mg each, 12 hours apart, or dose-matched placebo.
干预措施: Placebo (Drug)
Group 5: 1200 mg
All participants (fed) received either 1200 mg of danicopan as a single oral dose or dose-matched placebo.
干预措施: Danicopan (Drug)
Group 5: 1200 mg
All participants (fed) received either 1200 mg of danicopan as a single oral dose or dose-matched placebo.
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 28
次要结局
- Time To Reach The Maximal Plasma Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions(Up to 144 hours postdose)
- Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of Danicopan Under Both Fed And Fasted Conditions(Up to 144 hours postdose)
- Maximal Plasma Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions(Up to 144 hours postdose)
- Relationship Between Alternative Pathway Inhibition And Danicopan Plasma Concentrations(Up to 144 hours postdose)