A Study to Investigate Continuous Heart Rate Monitoring Using a Chest-worn Biosensor on the Background of Drug-induced Positive and Negative Heart Rate Changes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The mean change in heart rate (HR)
研究概览
简要总结
The main purpose of this study in healthy participants is to find out whether a heart rate monitor will accurately pick up changes in heart rate caused by 2 different medications (pseudoephedrine and metoprolol), on the background of daily activities. Participants will wear a patch heart rate and activity monitor on the chest for the entire study. The study will last about 36 days and may include up to seven visits to the study center.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males or females
- •Have a body mass index (BMI) of 18.0 to 35 kilograms/square meter (kg/m2), inclusive at screening
- •Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
- •Have given written informed consent approved by Lilly and the ethical review board governing the site
排除标准
- •Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- •Have history of sensitive skin or chronic skin conditions, like eczema
- •Regularly use known drugs of abuse
- •Are women who are pregnant or lactating
- •Have known allergies to medications used in the study
研究组 & 干预措施
Wearable Biosensor Patch Device + Propranolol
Participants will wear the biosensor patch device followed by propranolol administered orally in one of three study periods.
干预措施: Propranolol (Drug)
Wearable Biosensor Patch Device + Propranolol
Participants will wear the biosensor patch device followed by propranolol administered orally in one of three study periods.
干预措施: Wearable Biosensor Patch Device (Device)
Wearable Biosensor Patch Device + Pseudoephedrine
Participants will wear the biosensor patch device followed by pseudoephedrine administered orally in one of three study periods.
干预措施: Pseudoephedrine (Drug)
Wearable Biosensor Patch Device + Pseudoephedrine
Participants will wear the biosensor patch device followed by pseudoephedrine administered orally in one of three study periods.
干预措施: Wearable Biosensor Patch Device (Device)
Wearable Biosensor Patch Device (Alone)
Participants will wear biosensor patch device (alone) during one of three study periods.
干预措施: Wearable Biosensor Patch Device (Device)
结局指标
主要结局
The mean change in heart rate (HR)
时间窗: Day 1: Hour 1, Hour 4 post intervention
The mean change in HR
次要结局
未报告次要终点