A Study of Continuous Heart Rate Monitoring in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT04682184

Collaborator

(none)

Enrollment

Location

Arms

1.9

Actual Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Propranolol Drug: Pseudoephedrine Device: Wearable Biosensor Patch Device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jan 27, 2021

Actual Primary Completion Date :

Mar 25, 2021

Actual Study Completion Date :

Mar 25, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Wearable Biosensor Patch Device + Propranolol

Participants will wear the biosensor patch device followed by propranolol administered orally in one of three study periods.

Drug: Propranolol

Administered orally.

Device: Wearable Biosensor Patch Device

Biosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days.

Experimental: Wearable Biosensor Patch Device + Pseudoephedrine

Participants will wear the biosensor patch device followed by pseudoephedrine administered orally in one of three study periods.

Drug: Pseudoephedrine

Administered orally.

Device: Wearable Biosensor Patch Device

Biosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days.

Experimental: Wearable Biosensor Patch Device (Alone)

Participants will wear biosensor patch device (alone) during one of three study periods.

Device: Wearable Biosensor Patch Device

Biosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days.

Outcome Measures

Primary Outcome Measures

The mean change in heart rate (HR) [Day 1: Hour 1, Hour 4 post intervention]
The mean change in HR

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lilly Centre for Clinical Pharmacology	Singapore		Singapore	138623

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT04682184

Other Study ID Numbers:

18168
H6O-MC-O016

First Posted:

Dec 23, 2020

Last Update Posted:

Apr 19, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Propranolol

Pseudoephedrine

Ephedrine

Study Results

No Results Posted as of Apr 19, 2021