A Study of Continuous Heart Rate Monitoring in Healthy Participants

April 16, 2021 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 138623
        • Lilly Centre for Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2021

Primary Completion (Actual)

March 25, 2021

Study Completion (Actual)

March 25, 2021

Study Registration Dates

First Submitted

December 10, 2020

First Submitted That Met QC Criteria

December 21, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18168
  • H6O-MC-O016 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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