NCT06270511已完成1 期
A Phase 1, 2-Part Study to Evaluate the Relative Bioavailability of and Food-Effect on Pharmacokinetics of Different Formulations of S-337395, and to Assess the Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of S-337395 in Healthy Adult Participants
Shionogi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Part B: Number of Participants Experiencing Treatment-emergent Adverse Events
研究概览
简要总结
The aim of this study is to investigate different formulations of S-337395.
详细描述
This single-center study comprises an open-label, randomized, crossover study, and a double-blinded, placebo-controlled, randomized, multiple-dose study to examine the relative bioavailability, food effect, pharmacokinetics, safety, and tolerability of different formulations of S-337395.
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
盲法说明
Part A will be open label; Part B will be double blind
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
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •Body mass index within the range of 18.5 to approximately 30.0 kilograms/meter squared (inclusive) at screening.
- •Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies.
排除标准
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.
- •Lymphoma, leukemia, or any malignancy in the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- •Breast cancer within the past 10 years.
- •Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •Sensitivity to S-337395, or any components of the formulation, or drug or other allergy, that in the opinion of the investigator, contraindicates participation in the study.
- •Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part A: Open Label
Experimental
Participants will receive different formulations of S-337395 without food and with food.
干预措施: S-337395 (Drug)
Part B: Double Blind
Experimental
Participants will receive S-337395 or placebo.
干预措施: S-337395 (Drug)
Part B: Double Blind
Experimental
Participants will receive S-337395 or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Part B: Number of Participants Experiencing Treatment-emergent Adverse Events
时间窗: Day 1 through Day 21
Part A: Plasma Concentration of S-337395
时间窗: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose)
次要结局
- Part B: Plasma Concentration of S-337395(Days 1-12 (Predose, up to 96 hours post dose))
- Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples)(Venous: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose); Capillary: Days 1, 2, 8, and 9 (Up to 24 hours post dose))
- Part A: Number of Participants Experiencing Treatment-emergent Adverse Events(Day 1 through Day 29)
研究者
研究点 (1)
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