A Phase 1, Randomized, Open-Label, 2-Way Crossover Study to Assess the Single-Dose Pharmacokinetics of ALXN1840 Enteric-Coated Tablets at 2 Dose Strengths in Healthy Adult Subjects
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
- Maximum Observed (Plasma) Concentration (Cmax) of Total Molybdenum
研究概览
简要总结
To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter squared, inclusive, at Screening.
- •Negative serum pregnancy test at Screening and Day -1 for all women of childbearing potential.
- •Willing to adhere to contraception requirements.
- •Satisfactory medical assessment with no clinically significant or relevant abnormalities.
排除标准
- •Current or recurrent/chronic disease
- •Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody at Screening.
- •Acute or chronic hepatitis C virus infection.
- •History of hypersensitivity to ALXN1840 or its excipients or any significant allergic reaction.
- •Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
- •Participation (that is, last protocol-required study visit) in a clinical study within 90 days before initiation of dosing on Day
- •Serum ceruloplasmin value outside of the normal range at Screening
- •Female participants who were breastfeeding.
- •Prior exposure to ALXN
- •Major surgery or hospitalization within 90 days prior to dosing on Day 1.
研究组 & 干预措施
Sequence 1 (AB)
Participants received ALXN1840 once in each Period as a single oral dose under fasted conditions as follows:
Period 1: ALXN1840 as a single EC tablet (Treatment A, reference). Period 2: ALXN1840 as three EC tablets (Treatment B, test).
Participants were discharged following the 240-hour post-dose procedures (approximately 10 days after dosing in each period) unless it was medically necessary to extend the confinement.
There was a washout period of at least 14 days between each ALXN1840 dosing.
干预措施: ALXN1840 (Drug)
Sequence 2 (BA)
Participants received ALXN1840 once in each Period as a single oral dose under fasted conditions as follows:
Period 1: ALXN1840 as three EC tablets (Treatment B, test). Period 2: ALXN1840 as a single EC tablet (Treatment A, reference).
Participants were discharged following the 240-hour post-dose procedures (approximately 10 days after dosing in each period) unless it was medically necessary to extend the confinement.
There was a washout period of at least 14 days between each ALXN1840 dosing.
干预措施: ALXN1840 (Drug)
结局指标
主要结局
Maximum Observed (Plasma) Concentration (Cmax) of Total Molybdenum
时间窗: Up to 240 hours postdose
The pharmacokinetic (PK) data of plasma total molybdenum were analyzed in the scope of this study as a surrogate measure for ALXN1840. Whole blood samples were collected for the measurement of plasma concentrations of total molybdenum via inductively coupled plasma-mass spectroscopy (ICP-MS).
Area Under The Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt) of Total Molybdenum
时间窗: Up to 240 hours postdose
The PK data of plasma total molybdenum were analyzed in the scope of this study as a surrogate measure for ALXN1840. Whole blood samples were collected for the measurement of plasma concentrations of total molybdenum via ICP-MS.
次要结局
- Number of Participants With a Treatment-Emergent Adverse Event (TEAEs)(Baseline up to Day 43)