NCT06751017已完成1 期
A Phase 1 Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of S-892216 in Healthy Adult Participants
Shionogi1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年12月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Plasma Concentration of S-892216
研究概览
简要总结
The primary objective of this study is to investigate the effect of multiple-dose administration of carbamazepine on the pharmacokinetics of S-892216 in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Overtly healthy as determined by medical evaluation including medical history, medical examination, laboratory tests, vital sign measurements, and 12-lead electrocardiogram, at screening and on admission or participants whose laboratory values exceed the institutional reference range but deemed not clinically significant by the investigator in consideration of safety.
- •Body mass index ≥18.5 and ≤32.0 kilograms/meter squared.
排除标准
- •This study will not enroll participants with Asian ancestry, defined as individuals who have 1 or more Asian grandparent, due to significant increase of risk for carbamazepine-related serious dermatologic reactions almost exclusively in these populations.
- •Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (that is, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment.
- •History of adverse hematologic reaction to any drug, or a history of bone marrow depression.
- •History or family history of severe cutaneous reactions including toxic epidermal necrolysis and Stevens-Johnson Syndrome.
- •Prior carbamazepine use that was discontinued for tolerability or adverse events, including a clinically significant decrease in platelets, white blood cells, or hemoglobin.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
S-892216
Experimental
Participants will receive S-892216 and carbamazepine.
干预措施: S-892216 (Drug)
S-892216
Experimental
Participants will receive S-892216 and carbamazepine.
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Plasma Concentration of S-892216
时间窗: Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of S-892216
时间窗: Days 1 and 35 (2 hours predose, 30 minutes to 144 hours postdose)
Plasma Concentration of Carbamazepine
时间窗: Day 35 (2 hours predose, 30 minutes to 24 hours postdose)
Tmax of Carbamazepine
时间窗: Day 35 (2 hours predose, 30 minutes to 24 hours postdose)
次要结局
- Number of Participants Experiencing Treatment-emergent Adverse Events(Day 1 through Day 49)
研究者
研究点 (1)
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