NCT06106334已完成1 期
A Crossover, Phase 1, Open-label, One-arm Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Male and Female Participants
Shionogi1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年11月15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
- 14
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve Extrapolated From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) After Administration of S-309309
研究概览
简要总结
The primary purpose of this study is to determine the effect of repeated administration of itraconazole on the pharmacokinetic (PK) profile of S-309309; and the PK of S-309309 following administration of S-309309 alone and co-administration with itraconazole
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Participants who are considered to be medically healthy as determined by the investigator
- •Participants whose body mass index (BMI) is within the range of ≥ 18.5 to ≤ 30.0 kg/m^2
- •Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •Participants who understand the study procedures and agree to participate by providing written informed consent
- •Participants who are willing and able to comply with all study procedures and restrictions
排除标准
- •Participants who have a history of clinically significant hypersensitivity or severe side effects induced by a drug.
- •Participants who have a history of ventricular dysfunction, congestive heart failure, or pulmonary edema.
- •Participants who have a history of gastrointestinal surgery including, but not limited to, cholecystectomy, gastric resection, and/or intestinal resection that may result in a clinically significant abnormality in gastrointestinal function (except for an appendectomy). Participants can be considered by the investigator (or sub-investigator) to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immunological, neurological, or psychiatric disorders with clinical manifestations.
- •Participants who are considered inappropriate for participation in the study for any reason by the investigator (or sub-investigator).
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
S-309309
Experimental
All participants will receive each of the following treatments:
- Days 1 and 19: S-309309 once daily (QD); in the fasted state)
- Day 15: Itraconazole twice daily (BID); in the fed state)
- Days 16 to 24: Itraconazole QD (in the fed state, except for Day 19 [co-administration with S-309309 in the fasted state])
干预措施: S309309 (Drug)
S-309309
Experimental
All participants will receive each of the following treatments:
- Days 1 and 19: S-309309 once daily (QD); in the fasted state)
- Day 15: Itraconazole twice daily (BID); in the fed state)
- Days 16 to 24: Itraconazole QD (in the fed state, except for Day 19 [co-administration with S-309309 in the fasted state])
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve Extrapolated From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) After Administration of S-309309
时间窗: Up to 2 weeks postdose on Days 1, 19
Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Administration of S-309309
时间窗: Up to 2 weeks postdose on Days 1, 19
Maximum Observed Plasma Concentration (Cmax) After Administration of S-309309
时间窗: Up to 2 weeks postdose on Days 1, 19
次要结局
- Number of Participants With Adverse Events (AEs)(Up to 5 weeks)
研究者
研究点 (1)
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