A Multiple-Dose Drug-Drug Interaction Study to Determine the Effect of LY3437943 on Drug Metabolizing Enzymes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
研究概览
简要总结
The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants. This study will last up to approximately 25 weeks for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)
- •Male and female participants of childbearing potential who agree to use contraceptive methods
排除标准
- •Have a history of diabetes or current diagnosis of diabetes
- •History or presence of a of significant bleeding disorder
- •Participants with significant comorbidity
- •Participants receiving treatment with midazolam, warfarin, inhibitors or inducers of cytochrome P450 (CYP) -1A2, CYP2C9, or CYP3A4 enzymes, or drugs are CYP substrates and have a narrow therapeutic index
研究组 & 干预措施
LY3437943 + Drug Cocktail
Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1.
At weeks 8, 12, & 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2.
干预措施: LY3437943 (Drug)
LY3437943 + Drug Cocktail
Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1.
At weeks 8, 12, & 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2.
干预措施: Midazolam (Drug)
LY3437943 + Drug Cocktail
Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1.
At weeks 8, 12, & 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2.
干预措施: Warfarin (Drug)
LY3437943 + Drug Cocktail
Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1.
At weeks 8, 12, & 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2.
干预措施: Caffeine (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
时间窗: Predose up to 24 hours postdose
PK: AUC\[0-∞\] of Midazolam
PK: Maximum Observed Concentration (Cmax) of Midazolam
时间窗: Predose up to 24 hours postdose
PK: Cmax of Midazolam
PK: Cmax of Warfarin
时间窗: Predose up to 96 hours postdose
PK: Cmax of Warfarin
PK: Cmax of Caffeine
时间窗: Predose up to 48 hours postdose
PK: Cmax of Caffeine
PK: AUC[0-∞] of Warfarin
时间窗: Predose up to 96 hours postdose
PK: AUC\[0-∞\] of Warfarin
PK: AUC[0-∞] of Caffeine
时间窗: Predose up to 48 hours postdose
PK: AUC\[0-∞\] of Caffeine
次要结局
未报告次要终点