A Phase 1 Study To Determine The Relative Bioavailability Of ACH-0144471 After Administration Of A Tablet Or Softgel Capsule Versus A Liquid Filled Capsule In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations
研究概览
简要总结
This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule [LFC]) in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 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 examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
- •Had a 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.
- •History of procedures that could alter absorption of orally administered drugs.
- •Body temperature ≥ 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.
- •Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.
- •Participation in a clinical study within 30 days prior to study drug administration.
- •Clinically significant laboratory abnormalities at Screening or Day -1.
研究组 & 干预措施
Group 1: Sequence 1
Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 3: Danicopan as a tablet under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
干预措施: Danicopan - Tablet (Drug)
Group 1: Sequence 1
Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 3: Danicopan as a tablet under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
干预措施: Danicopan - LFC (Drug)
Group 1: Sequence 2
Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 2: Danicopan as a tablet under fasted conditions. Period 3: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
干预措施: Danicopan - Tablet (Drug)
Group 1: Sequence 2
Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 2: Danicopan as a tablet under fasted conditions. Period 3: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
干预措施: Danicopan - LFC (Drug)
Group 1: Sequence 3
Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as a tablet under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. Period 3: Danicopan as a tablet under fed (medium-fat meal) conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
干预措施: Danicopan - Tablet (Drug)
Group 1: Sequence 3
Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:
Period 1: Danicopan as a tablet under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. Period 3: Danicopan as a tablet under fed (medium-fat meal) conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
干预措施: Danicopan - LFC (Drug)
Group 2: Sequence 1
Participants received danicopan once each period as a single dose under fasted conditions as follows:
Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a softgel capsule under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
干预措施: Danicopan - Softgel (Drug)
Group 2: Sequence 1
Participants received danicopan once each period as a single dose under fasted conditions as follows:
Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a softgel capsule under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
干预措施: Danicopan - LFC (Drug)
Group 2: Sequence 2
Participants received danicopan once each period as a single dose under fasted conditions as follows:
Period 1: Danicopan as a softgel capsule under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
干预措施: Danicopan - Softgel (Drug)
Group 2: Sequence 2
Participants received danicopan once each period as a single dose under fasted conditions as follows:
Period 1: Danicopan as a softgel capsule under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
干预措施: Danicopan - LFC (Drug)
结局指标
主要结局
PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations
时间窗: Up to 96 hours postdose
PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations
时间窗: Up to 96 hours postdose
PK: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-Inf) Of Danicopan After Treatment With Each Of The Three Formulations
时间窗: Up to 96 hours postdose
次要结局
- PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions(Up to 96 hours postdose)
- PK: Tmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions(Up to 96 hours postdose)
- PK: AUC0-inf Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions(Up to 96 hours postdose)
- Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation(Day 1 through Day 39)