A Study of Continuous Heart Rate Monitoring in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Propranolol
* Drug: Pseudoephedrine
* Device: Wearable Biosensor Patch Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable Biosensor Patch Device + Propranolol<br>Participants will wear the biosensor patch device followed by propranolol administered orally in one of three study periods. | Drug: Propranolol<br>* Administered orally.<br>Device: Wearable Biosensor Patch Device<br>* Biosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days.<br>|
| Experimental: Wearable Biosensor Patch Device + Pseudoephedrine<br>Participants will wear the biosensor patch device followed by pseudoephedrine administered orally in one of three study periods. | Drug: Pseudoephedrine<br>* Administered orally.<br>Device: Wearable Biosensor Patch Device<br>* Biosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days.<br>|
| Experimental: Wearable Biosensor Patch Device (Alone)<br>Participants will wear biosensor patch device (alone) during one of three study periods. | Device: Wearable Biosensor Patch Device<br>* Biosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in heart rate (HR) | The mean change in HR | Day 1: Hour 1, Hour 4 post intervention |