A 2-Part, Open-Label, Randomized, Single-Dose, 3-Period Crossover, Phase 1, Relative Bioavailability, and Food Effect Study, Comparing Different Formulations of Danicopan in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Time to maximum observed plasma concentration (Tmax) Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
研究概览
简要总结
This is a 2-part open-label, randomized, single-dose, 3-sequence, 3-period crossover, relative bioavailability, and food-effect study comparing different formulations of danicopan in healthy adult participants.
详细描述
For both parts of this study, on Day 1 of each period, participants will receive a single oral dose of danicopan as either the prototype powder-in-capsule (PIC) formulation (1 or 2) under fed conditions, the prototype PIC formulation (1 or 2) under fasting conditions, or the tablet formulation under fed conditions.
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
- •No clinically significant findings at screening (medical history, clinical laboratory profiles, and electrocardiograms).
- •Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
- •Female participants of childbearing potential must either agree to abstinence or to use, with their male partner, a highly effective method of contraception .
- •Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
排除标准
- •History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
- •History or presence of drug or alcohol abuse within previous 2 years, current tobacco user, or positive drugs-of-abuse screen or alcohol screen at screening or Day -1 of Period
- •History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
- •History of procedures that could alter absorption or excretion of orally administered drugs.
- •History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
- •Body temperature ≥ 38.0°Celcius at screening or prior to first dosing or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
- •Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.
- •Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, receipt of blood products within 6 months prior to first dosing, or receipt of a vaccine within 30 days prior to first dosing.
- •Is a female with a positive pregnancy test or who is lactating.
研究组 & 干预措施
Part 1: Sequence 1
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 1 formulation under fed conditions. Period 2: Danicopan as the PIC 1 formulation under fasted conditions. Period 3: Danicopan as a tablet under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Powder-In-Capsule 1 (Drug)
Part 1: Sequence 1
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 1 formulation under fed conditions. Period 2: Danicopan as the PIC 1 formulation under fasted conditions. Period 3: Danicopan as a tablet under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Tablet (Drug)
Part 1: Sequence 2
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 1 formulation under fasted conditions. Period 2: Danicopan as a tablet under fed conditions. Period 3: Danicopan as the PIC 1 formulation under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Powder-In-Capsule 1 (Drug)
Part 1: Sequence 2
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 1 formulation under fasted conditions. Period 2: Danicopan as a tablet under fed conditions. Period 3: Danicopan as the PIC 1 formulation under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Tablet (Drug)
Part 1: Sequence 3
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as a tablet under fed conditions. Period 2: Danicopan as the PIC 1 formulation under fed conditions. Period 3: Danicopan as the PIC 1 formulation under fasted conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Powder-In-Capsule 1 (Drug)
Part 1: Sequence 3
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as a tablet under fed conditions. Period 2: Danicopan as the PIC 1 formulation under fed conditions. Period 3: Danicopan as the PIC 1 formulation under fasted conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Tablet (Drug)
Part 2: Sequence 1
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 2 formulation under fed conditions. Period 2: Danicopan as the PIC 2 formulation under fasted conditions. Period 3: Danicopan as a tablet under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Powder-In-Capsule 2 (Drug)
Part 2: Sequence 1
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 2 formulation under fed conditions. Period 2: Danicopan as the PIC 2 formulation under fasted conditions. Period 3: Danicopan as a tablet under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Tablet (Drug)
Part 2: Sequence 2
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 2 formulation under fasted conditions. Period 2: Danicopan as a tablet under fed conditions. Period 3: Danicopan as the PIC 2 formulation under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Powder-In-Capsule 2 (Drug)
Part 2: Sequence 2
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as the PIC 2 formulation under fasted conditions. Period 2: Danicopan as a tablet under fed conditions. Period 3: Danicopan as the PIC 2 formulation under fed conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Tablet (Drug)
Part 2: Sequence 3
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as a tablet under fed conditions. Period 2: Danicopan as the PIC 2 formulation under fed conditions. Period 3: Danicopan as the PIC 2 formulation under fasted conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Powder-In-Capsule 2 (Drug)
Part 2: Sequence 3
Participants will receive danicopan once each period as a single oral dose under fasted or fed conditions as follows:
Period 1: Danicopan as a tablet under fed conditions. Period 2: Danicopan as the PIC 2 formulation under fed conditions. Period 3: Danicopan as the PIC 2 formulation under fasted conditions.
There will be a washout period of at least 5 days between each danicopan dosing.
干预措施: Danicopan: Tablet (Drug)
结局指标
主要结局
Time to maximum observed plasma concentration (Tmax) Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
时间窗: Up to 72 hours postdose
AUC0-inf Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
时间窗: Up to 72 hours postdose
AUC0-t Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
时间窗: Up to 72 hours postdose
Tmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
时间窗: Up to 72 hours postdose
AUC0-inf Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
时间窗: Up to 72 hours postdose
Relative Bioavailability Of Danicopan Prototype PIC 2 Formulation And Tablet Formulation
时间窗: Up to 72 hours postdose
The relative bioavailability of the PIC 2 formulation versus the tablet formulation will be measured by the ratio of select PK parameters: Cmax, AUC0-t, and AUC0-inf.
Cmax Of Danicopan Prototype PIC 2 Formulation Under Both Fed And Fasted Conditions
时间窗: Up to 72 hours postdose
Relative Bioavailability Of Danicopan Prototype PIC 1 Formulation And Tablet Formulation
时间窗: Up to 72 hours postdose
The relative bioavailability of the PIC 1 formulation versus the tablet formulation will be measured by the ratio of select pharmacokinetic (PK) parameters: maximum observed plasma concentration (Cmax), area under the concentration-time curve from time of administration to the last measurable concentration (AUC0-t), and area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf).
Cmax Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
时间窗: Up to 72 hours postdose
AUC0-t Of Danicopan Prototype PIC 1 Formulation Under Both Fed And Fasted Conditions
时间窗: Up to 72 hours postdose
次要结局
- Number Of Participants Receiving Prototype PIC 1 With Treatment-emergent Adverse Events Under Fasted Conditions(Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1))
- Number Of Participants Receiving Prototype PIC 2 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions(Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1))
- Number Of Participants Receiving Prototype PIC 2 With Treatment-emergent Adverse Events Under Fasted Conditions(Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1))
- Number Of Participants Receiving Prototype PIC 1 And Tablet With Treatment-emergent Adverse Events Under Fed Conditions(Day 1 (postdose) through follow-up (10 [+/- 2] days dosing on Day 1))