A Study of Continuous Heart Rate Monitoring in Healthy Participants

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Propranolol; Drug: Pseudoephedrine; Device: Wearable Biosensor Patch Device

• Registration Number: NCT04682184
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-10
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-23
• Study Start: 2021-01-27
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-25
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Wearable Biosensor Patch Device + Propranolol	Wearable Biosensor Patch Device	Participants will wear the biosensor patch device followed by propranolol administered orally in one of three study periods.
Wearable Biosensor Patch Device (Alone)	Wearable Biosensor Patch Device	Participants will wear biosensor patch device (alone) during one of three study periods.
Wearable Biosensor Patch Device + Pseudoephedrine	Wearable Biosensor Patch Device	Participants will wear the biosensor patch device followed by pseudoephedrine administered orally in one of three study periods.
Wearable Biosensor Patch Device + Propranolol	Propranolol	Participants will wear the biosensor patch device followed by propranolol administered orally in one of three study periods.
Wearable Biosensor Patch Device + Pseudoephedrine	Pseudoephedrine	Participants will wear the biosensor patch device followed by pseudoephedrine administered orally in one of three study periods.

Primary Outcome Measures

Name	Time	Method
The mean change in heart rate (HR)	Day 1: Hour 1, Hour 4 post intervention	The mean change in HR

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore