A Phase 1 Two-Part Study to Evaluate the Potential Drug Interactions Between ALXN2050 and Fluconazole, and Between ALXN2050 and Rifampin in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Part 1: Area Under The Concentration-time Curve From Time 0 To Infinity (AUC0-inf) For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole
研究概览
简要总结
This is a 2-part, open label, fixed-sequence study to evaluate the potential drug interaction between ALXN2050 and fluconazole (Part 1), and between ALXN2050 and rifampin (Part 2) in healthy adult participants. Part 1 will be a 2-period, fixed-sequence study. Part 2 will be a single-period, fixed-sequence study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles.
- •Body mass index within the range 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.
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 of significant multiple and/or severe allergies.
- •Any previous procedure that could alter absorption or excretion of orally administered drugs.
- •Participation in another investigational drug or investigational device study within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
- •Body temperature ≥ 38.0°Celsius, at Screening or prior to the first dose of study intervention.
- •History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco/nicotine user or smoker or a positive cotinine test at Screening.
- •Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.
研究组 & 干预措施
Part 1: ALXN2050 plus Fluconazole
Period 1: Participants will receive a single dose of ALXN2050 alone and in the presence of multiple doses of fluconazole.
Period 2: Participants will receive multiple doses of ALXN2050 alone and in the presence of multiple doses of fluconazole.
Scheduled pharmacokinetics (PK) blood samples for both ALXN2050 and fluconazole will be collected, with a washout period of at least 14 days between the last dose of fluconazole in Period 1 and the first dose of ALXN2050 in Period 2.
干预措施: ALXN2050 (Drug)
Part 1: ALXN2050 plus Fluconazole
Period 1: Participants will receive a single dose of ALXN2050 alone and in the presence of multiple doses of fluconazole.
Period 2: Participants will receive multiple doses of ALXN2050 alone and in the presence of multiple doses of fluconazole.
Scheduled pharmacokinetics (PK) blood samples for both ALXN2050 and fluconazole will be collected, with a washout period of at least 14 days between the last dose of fluconazole in Period 1 and the first dose of ALXN2050 in Period 2.
干预措施: Fluconazole (Drug)
Part 2: ALXN2050 plus Rifampin
Participants will receive a single dose of ALXN2050 alone and in the presence of both single and multiple doses of rifampin.
Scheduled PK blood samples for both ALXN2050 and rifampin will be collected.
干预措施: ALXN2050 (Drug)
Part 2: ALXN2050 plus Rifampin
Participants will receive a single dose of ALXN2050 alone and in the presence of both single and multiple doses of rifampin.
Scheduled PK blood samples for both ALXN2050 and rifampin will be collected.
干预措施: Rifampin (Drug)
结局指标
主要结局
Part 1: Area Under The Concentration-time Curve From Time 0 To Infinity (AUC0-inf) For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole
时间窗: Up to 72 hours postdose
Part 1: Time To Maximum Plasma Concentration (Tmax) For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole
时间窗: Up to 72 hours postdose
Part 1: Maximum Observed Concentration (Cmax) For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole
时间窗: Up to 72 hours postdose
Part 1: Area Under The Concentration-time Curve From Time 0 To The 12-hour Point (AUC0-12) For Multiple Doses Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole
时间窗: Up to 72 hours postdose
Part 1: Cmax For Multiple Doses Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole
时间窗: Up to 72 hours postdose
Part 1: Tmax For Multiple Doses Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Fluconazole
时间窗: Up to 72 hours postdose
Part 2: AUC0-inf For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed With A Single Dose Of Rifampin
时间窗: Up to 72 hours postdose
Part 2: Cmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed With A Single Dose Of Rifampin
时间窗: Up to 72 hours postdose
Part 2: Tmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed With A Single Dose Of Rifampin
时间窗: Up to 72 hours postdose
Part 2: AUC0-inf For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Rifampin
时间窗: Up to 72 hours postdose
Part 2: Cmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Rifampin
时间窗: Up to 72 hours postdose
Part 2: Tmax For A Single Dose Of ALXN2050 When Dosed Alone Versus When Dosed In The Presence Of Steady-state Rifampin
时间窗: Up to 72 hours postdose
次要结局
- Part 1: Area Under The Concentration-time Curve From Time Zero To The 4-hour Time Point (AUC0-4) For ALXN2050 When Dosed In The Morning Versus In The Evening(Up to 12 hours postdose)
- Participants Experiencing Treatment-emergent Adverse Events(Up to 40 days postdose)