A Phase 1, Randomized, Open-label, Parallel-group, Drug-drug Interaction Study to Evaluate the Effect of Antiemetic Medication on the Pharmacokinetics of AMG 133 in Participants Living With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of AMG 133
研究概览
简要总结
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of AMG 133 administered alone and in combination with an antiemetic medication, ondansetron, in participants living with overweight or obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Low Dose AMG 133 without Ondansetron
Participants will receive a single subcutaneous (SC) low dose of 70 mg AMG 133.
干预措施: AMG 133 (Drug)
High Dose AMG 133 without Ondansetron
Participants will receive a single SC high dose of 350 mg AMG 133.
干预措施: AMG 133 (Drug)
Low Dose AMG 133 with Ondansetron
Participants will receive a single SC low dose of 70 mg AMG 133 and ondansetron 8 mg orally disintegrating tablet (ODT) every 8 hours for 72 hours.
干预措施: AMG 133 (Drug)
Low Dose AMG 133 with Ondansetron
Participants will receive a single SC low dose of 70 mg AMG 133 and ondansetron 8 mg orally disintegrating tablet (ODT) every 8 hours for 72 hours.
干预措施: Ondansetron (Drug)
High Dose AMG 133 with Ondansetron
Participants will receive a single SC high dose of 350 mg AMG 133 and ondansetron 8mg ODT every 8 hours for 72 hours.
干预措施: AMG 133 (Drug)
High Dose AMG 133 with Ondansetron
Participants will receive a single SC high dose of 350 mg AMG 133 and ondansetron 8mg ODT every 8 hours for 72 hours.
干预措施: Ondansetron (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of AMG 133
时间窗: Up to Day 120
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of AMG 133
时间窗: Up to Day 120
AUC from Time Zero to Infinity (AUCinf) of AMG 133
时间窗: Up to Day 120
次要结局
- Number of Participants with Serious AEs (SAEs)(Up to Day 120)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to Day 120)
- Number of Participants with Anti-AMG 133 Antibodies(Up to Day 120)