NCT05568082已完成1 期
An Open-label Study to Evaluate the Drug-drug Interaction Effect of Itraconazole, a CYP3A4 Inhibitor, on the Pharmacokinetics of AMG 510 in Healthy Subjects
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
- Amgen
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- AUC from Time Zero to Infinity (AUCinf) of AMG 510
研究概览
简要总结
The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of AMG 510 administered alone and in combination with itraconazole in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening.
- •Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
- •Females of nonchildbearing potential
排除标准
- •Inability to swallow oral medication or history of malabsorption syndrome.
- •History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
- •Poor peripheral venous access.
- •History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
研究组 & 干预措施
AMG 510 + Itraconazole
Experimental
干预措施: AMG 510 (Drug)
AMG 510 + Itraconazole
Experimental
干预措施: Itraconazole (Drug)
结局指标
主要结局
AUC from Time Zero to Infinity (AUCinf) of AMG 510
时间窗: Day 1 and Day 6
Maximum Observed Plasma Concentration (Cmax) of AMG 510
时间窗: Day 1 and Day 6
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 510
时间窗: Day 1 and Day 6
次要结局
- Cmax of AMG 510 Metabolite M24(Day 1 and Day 6)
- AUClast of AMG 510 Metabolite M24(Day 1 and Day 6)
- Number of Participants with an Adverse Event (AE)(Day 1 to Day 8)
- AUCinf of AMG 510 Metabolite M24(Day 1 and Day 6)
研究者
研究点 (1)
Loading locations...
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