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
Overview
- Phase
- N/A
- Intervention
- Propranolol
- Conditions
- Healthy
- Sponsor
- Eli Lilly and Company
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- The mean change in heart rate (HR)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Wearable Biosensor Patch Device + Propranolol
Participants will wear the biosensor patch device followed by propranolol administered orally in one of three study periods.
Intervention: Propranolol
Wearable Biosensor Patch Device + Propranolol
Participants will wear the biosensor patch device followed by propranolol administered orally in one of three study periods.
Intervention: Wearable Biosensor Patch Device
Wearable Biosensor Patch Device + Pseudoephedrine
Participants will wear the biosensor patch device followed by pseudoephedrine administered orally in one of three study periods.
Intervention: Pseudoephedrine
Wearable Biosensor Patch Device + Pseudoephedrine
Participants will wear the biosensor patch device followed by pseudoephedrine administered orally in one of three study periods.
Intervention: Wearable Biosensor Patch Device
Wearable Biosensor Patch Device (Alone)
Participants will wear biosensor patch device (alone) during one of three study periods.
Intervention: Wearable Biosensor Patch Device
Outcomes
Primary Outcomes
The mean change in heart rate (HR)
Time Frame: Day 1: Hour 1, Hour 4 post intervention
The mean change in HR