An Open-label, Randomized, 2-period, 2-treatment Crossover Study to Assess the Effect of Food on the Pharmacokinetics of AMG 510 in Healthy Subjects
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
- Maximum Plasma Concentration (Cmax) of AMG 510
研究概览
简要总结
The primary objective of the study is to evaluate the PK of AMG 510 administered in the fasted and fed state in healthy participants.
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
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 participants or female participants, 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
Treatment Sequence AB
Participants will be administered AMG 510 orally in the following order:
Period 1 (treatment A) - AMG 510 under fasted conditions. Period 2 (treatment B) - AMG 510 under fed conditions.
干预措施: AMG 510 (Drug)
Treatment Sequence BA
Participants will be administered AMG 510 orally in the following order:
Period 1 (treatment B) - AMG 510 under fed conditions. Period 2 (treatment A) - AMG 510 under fasted conditions.
干预措施: AMG 510 (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of AMG 510
时间窗: Day 1 and Day 4
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510
时间窗: Day 1 and Day 4
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510
时间窗: Day 1 and Day 4
次要结局
- AUCinf of AMG 510 Metabolite M24(Day 1 and Day 4)
- Number of Participants with an Adverse Event (AE)(Day 1 to Day 6)
- Cmax of AMG 510 Metabolite M24(Day 1 and Day 4)
- AUClast of AMG 510 Metabolite M24(Day 1 and Day 4)