NCT07011992已完成1 期
A Phase 1, Open-label, 1-Sequence Crossover, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of BPN14770 on the Pharmacokinetics of Rosuvastatin in Healthy Adult Participants
Shionogi1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年7月18日最近更新:
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
- 12
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of Rosuvastatin
研究概览
简要总结
The primary objective of this study is to investigate the effects of BPN14770 on the pharmacokinetics of the breast cancer resistance protein and organic anion transporting polypeptide 1B1 substrate rosuvastatin 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
- •All female participants must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations)
排除标准
- •Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (that is, increased intraocular 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
- •Known history of allergic reaction to multiple medications and/or severe allergic reaction to any food or environmental allergens
- •Prior use of rosuvastatin that was discontinued for tolerability or adverse events
- •Received ≥4 types of investigational study interventions within 12 months prior to administration of study intervention
- •Positive drug or alcohol screen test result at screening or upon admission
- •Use of cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission
- •Note: Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BPN14770
Experimental
Participants will receive rosuvastatin and BPN14770.
干预措施: Rosuvastatin (Drug)
BPN14770
Experimental
Participants will receive rosuvastatin and BPN14770.
干预措施: BPN14770 (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Rosuvastatin
时间窗: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin
时间窗: Days 1 and 11 (pre-dose, up to 72 hours post-dose)
次要结局
- Cmax of BPN14770(Day 11 (pre-dose, up to 72 hours post-dose))
- Tmax of BPN14770(Day 11 (pre-dose, up to 72 hours post-dose))
- Cmax of Coproporphyrin I(Days 1 and 11 (pre-dose, up to 72 hours post-dose))
- Tmax of Coproporphyrin I(Days 1 and 11 (pre-dose, up to 72 hours post-dose))
- Number of Participants Experiencing Treatment-emergent Adverse Events(Day 1 through Day 21)
研究者
研究点 (1)
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