NCT05550129已完成1 期
A Phase I, Open-label Study to Evaluate the Drug-drug Interactions Between Metformin and 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
- 13
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of Metformin
研究概览
简要总结
The primary objectives of this study are to evaluate the effect of AMG 510 on the pharmacokinetics (PK) of metformin in healthy participants and to evaluate the effect of metformin on the PK of AMG 510 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 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/m^2 (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 participant safety or interfere with the study evaluation, procedures, or completion.
研究组 & 干预措施
AMG 510 + Metformin
Experimental
干预措施: AMG 510 (Drug)
AMG 510 + Metformin
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of Metformin
时间窗: Day 1 and Day 8
Area Under the Plasma Concentration Time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of Metformin
时间窗: Day 1 and Day 8
AUC from Time Zero to Infinity (AUCinf) of Metformin
时间窗: Day 1 and Day 8
Cmax of AMG 510
时间窗: Day 4 and Day 8
AUClast of AMG 510
时间窗: Day 4 and Day 8
AUCinf of AMG 510
时间窗: Day 4 and Day 8
次要结局
- Number of Participants with an Adverse Event (AE)(Day 1 to Day 10)
- Plasma Concentration of AMG 510 Metabolite M24(Day 4 and Day 8)
- Urine Concentration of Metformin(Day 1 and Day 8)
- Cmax of Metformin(Day 4 and Day 8)
- AUCinf of Metformin(Day 4 and Day 8)
- AUClast of Metformin(Day 4 and Day 8)
- Rate of Renal Clearance of Metformin(Day 4 and Day 8)
- Area Under the Glucose Concentration-time Curve from Time 0 to 2 Hours After Glucose Administration (AUC0-2)(Day 1, Day 4 and Day 8)
研究者
研究点 (1)
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