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OpenTrials
Completed

NCT Number: NCT04682184

A Study of Continuous Heart Rate Monitoring in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propranolol

Drug

Administered orally.

pseudoephedrine

Drug

Administered orally.

Wearable Biosensor Patch Device

Device

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

Primary outcomes

  1. The mean change in heart rate (HR)

    Time frame: Day 1: Hour 1, Hour 4 post intervention

    The mean change in HR

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2020
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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