A Study of Continuous Heart Rate Monitoring in Healthy Participants

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 25, 2021

Interventions

  • Drug: Propranolol
    • Administered orally.
  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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), Study Director, Eli Lilly and Company

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