A Study of Continuous Heart Rate Monitoring in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-27

Study Completion Date

2021-03-25

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Wearable Biosensor Patch Device + Propranolol

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

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

Administered orally.

Wearable Biosensor Patch Device

Intervention Type DEVICE

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

Wearable Biosensor Patch Device + Pseudoephedrine

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

Group Type EXPERIMENTAL

Pseudoephedrine

Intervention Type DRUG

Administered orally.

Wearable Biosensor Patch Device

Intervention Type DEVICE

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

Wearable Biosensor Patch Device (Alone)

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

Group Type EXPERIMENTAL

Wearable Biosensor Patch Device

Intervention Type DEVICE

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

Interventions

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Propranolol

Administered orally.

Intervention Type DRUG

Pseudoephedrine

Administered orally.

Intervention Type DRUG

Wearable Biosensor Patch Device

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes