A Phase 1, Randomized, 2-period, 2-sequence, Crossover With Parallel-group Extension, Open-label Study to Compare the Relative Bioavailability of 2 Oral Formulations of ALXN1840 in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Two-way Crossover Period: Cmax for PUF Mo
研究概览
简要总结
The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in healthy participants.
详细描述
This is a two-way crossover study consisting of 2 dosing periods assessing a test and reference formulation of ALXN1840. A dose-proportionality parallel group design extension period will be conducted following completion of the two-way crossover period of the study and will assess 5 different ascending doses of ALXN1840. There will be at least a 14-day washout following doses between Periods 1 and 2 and also at least a 14-day washout following the dose in Period 2 and the following dose in the Dose-Proportionality Extension Period.
Safety will be assessed throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 history or presence of electrocardiogram findings
- •Body weight ≥50 to ≤100 kilograms (kg) and body mass index 18 to <32 kg/meter squared for all participants
- •Willing and able to follow protocol-specified contraception requirements
排除标准
- •History or presence of clinical and/or laboratory disorders
- •Abnormal blood pressure, defined as supine blood pressure ≤90/60 millimeters of mercury (mmHg) or >140/90 mmHg
- •Lymphoma, leukemia, or any malignancy within the past 5 years
- •Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > upper limit of normal
- •Serum copper or serum ceruloplasmin below lower limit of normal
- •Hemoglobin <130 grams (g)/liter (L) for males and hemoglobin <115 g/L for females
- •Significant allergies
研究组 & 干预措施
Crossover ALXN1840 Sequence 1
Participants will first receive a single dose of ALXN1840 test formulation on Day 1 of Period 1. After a washout period of 14 days, they will then receive a single dose of ALXN1840 reference formulation on Day 1 of Period 2.
干预措施: ALXN1840 (Drug)
Crossover ALXN1840 Sequence 2
Participants will first receive a single dose of ALXN1840 reference formulation on Day 1 of Period 1. After a washout period of 14 days, they will then receive a single dose of ALXN1840 test formulation on Day 1 of Period 2.
干预措施: ALXN1840 (Drug)
Parallel Dose-proportionality Extension: ALXN1840 Dose 1
Participants will receive a single dose of ALXN1840.
干预措施: ALXN1840 (Drug)
Parallel Dose-proportionality Extension: ALXN1840 Dose 2
Participants will receive a single dose of ALXN1840.
干预措施: ALXN1840 (Drug)
Parallel Dose-proportionality Extension: ALXN1840 Dose 3
Participants will receive a single dose of ALXN1840.
干预措施: ALXN1840 (Drug)
Parallel Dose-proportionality Extension: ALXN1840 Dose 4
Participants will receive a single dose of ALXN1840.
干预措施: ALXN1840 (Drug)
结局指标
主要结局
Two-way Crossover Period: Cmax for PUF Mo
时间窗: predose (0.5 hour) and up to 336 hours postdose
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo
时间窗: predose (0.5 hour) and up to 336 hours postdose
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo)
时间窗: predose (0.5 hour) and up to 336 hours postdose
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via inductively coupled plasma-mass spectroscopy (ICP-MS).
Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) For Plasma Total Mo
时间窗: predose (0.5 hour) and up to 336 hours postdose
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Two-way Crossover Period: AUCt for Plasma PUF Mo
时间窗: predose (0.5 hour) and up to 336 hours postdose
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
次要结局
- Dose-Proportionality Extension Period: AUCinf For Plasma Total Mo(predose (0.5 hour) and up to 336 hours postdose)
- Dose-Proportionality Extension Period: AUCt For Plasma PUF Mo(predose (0.5 hour) and up to 336 hours postdose)
- Dose-Proportionality Extension Period: Cmax For Plasma Total Mo(predose (0.5 hour) and up to 336 hours postdose)
- Dose-Proportionality Extension Period: Cmax For Plasma PUF Mo(predose (0.5 hour) and up to 336 hours postdose)
- Dose-Proportionality Extension Period: AUCt For Plasma Total Mo(predose (0.5 hour) and up to 336 hours postdose)