A Study of Continuous Heart Rate Monitoring in Healthy Participants

Lilly

Status: Completed

Conditions: Healthy

Treatments: Device: Wearable Biosensor Patch Device; Drug: Propranolol; Drug: Pseudoephedrine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04682184

18168

H6O-MC-O016 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Wearable Biosensor Patch Device + Propranolol

Experimental group

Description:

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

Treatment:

Device: Wearable Biosensor Patch Device

Drug: Propranolol

Wearable Biosensor Patch Device + Pseudoephedrine

Experimental group

Description:

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

Treatment:

Drug: Pseudoephedrine

Device: Wearable Biosensor Patch Device

Wearable Biosensor Patch Device (Alone)

Experimental group

Description:

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

Treatment:

Device: Wearable Biosensor Patch Device