A Study of Continuous Heart Rate Monitoring in Healthy Participants

Eli Lilly and Company21 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

PropranololDRUG

Administered orally.

PseudoephedrineDRUG

Administered orally.

Wearable Biosensor Patch DeviceDEVICE

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Lilly Centre for Clinical Pharmacology

Singapore, Singapore

Outcomes

Primary Outcomes

The mean change in heart rate (HR)

The mean change in HR

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

Data from ClinicalTrials.gov

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