An Open-label, Randomized, 2-sequence, 2-period, 2-treatment, 2-part Study to Evaluate the Relative Bioavailability of SAR443820 in Tablet Formulation Versus Capsule Formulation in Fasted Condition (Part 1) and the Food-effect on SAR443820 in Tablet Formulation (Part 2) in Healthy Adult Male and Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Part 1: Maximum plasma concentration observed (Cmax)
研究概览
简要总结
Part 1:
This is an open label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment A and Treatment B for Part 1), study part to determine the relative bioavailability of SAR443820 in tablet formulation versus capsule formulation under fasted conditions.
Two treatments are as follows:
- Treatment A: SAR443820 - tablet formulation in fasted condition
- Treatment B: SAR443820 - capsule formulation in fasted condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days.
Part 2:
This is an open-label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment C and Treatment D for Part 2) study part to perform a preliminary assessment of the effect of a high-fat meal on pharmacokinetic parameters of single dose of SAR443820 in tablet formulation.
Two treatments are as follows:
- Treatment C: SAR443820 - tablet formulation in fasted condition
- Treatment D: SAR443820 - tablet formulation in fed condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days.
Participants are not allowed to participate in more than one part of the study. In both Parts 1 and 2, the assessment of pharmacokinetic, safety and tolerability are performed at each treatment period at baseline (prior single dosing) up to 48-hour postdosing in healthy adult male and female participants.
详细描述
Screening period: up to 4 weeks (Day -28 to Day -2). In both Part 1 and Part 2: Period 1: Day -1 to Day 3 and 5 days wash out period. Period 2: Day -1 to Day 3 and until end-of-study visit at Day 6.
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
- •Male or female participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- •Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m^2, inclusive
- •All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •Having given written informed consent prior to undertaking any study-related procedure
排除标准
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness
- •Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any non-live Covid-19 vaccine within the last 2 weeks before randomization, any live attenuated vaccine within the last 28 days before randomization and any other non-vaccine biological drugs given within 4 months before randomization
- •Positive result for hepatitis B, C or human immunodeficiency virus (HIV)
- •Positive result on urine drug screen
- •Positive urine alcohol test
- •Positive severe acute respiratory syndrom coronavirus 2 (SARS-CoV-2) test
- •Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 5 days before inclusion
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Treatment A
Single dose of SAR443820 tablet in fasted condition
干预措施: SAR443820 (Drug)
Treatment D
Single dose of SAR443820 tablet in fed condition
干预措施: SAR443820 (Drug)
Treatment B
Single dose of SAR443820 capsule in fasted condition
干预措施: SAR443820 (Drug)
Treatment C
Single dose of SAR443820 tablet in fasted condition
干预措施: SAR443820 (Drug)
结局指标
主要结局
Part 1: Maximum plasma concentration observed (Cmax)
时间窗: In both Period 1 and Period 2: From Day 1 to Day 3
Part 2: Maximum plasma concentration observed (Cmax)
时间窗: In both Period 1 and Period 2: From Day 1 to Day 3
Part 1: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast)
时间窗: In both Period 1 and Period 2: From Day 1 to Day 3
Part 2: Area under the plasma concentration from time zero to the last concentration above the limit of quantification (AUClast)
时间窗: In both Period 1 and Period 2: From Day 1 to Day 3
Part 2: Area under the plasma concentration (AUC)
时间窗: In both Period 1 and Period 2: From Day 1 to Day 3
Part 1: Area under the plasma concentration (AUC)
时间窗: In both Period 1 and Period 2: From Day 1 to Day 3
次要结局
- Part 1: Number of participants with treatment emergent adverse events (TEAEs)(In both Period 1 and Period 2: From Day 1 to Day 4)
- Part 2: Number of participants with treatment emergent adverse events (TEAEs)(In both Period 1 and Period 2: From Day 1 to Day 4)