A Study of Continuous Heart Rate Monitoring in Healthy Participants

NCT04682184 | Completed

• 2 other identifiers: 18168H6O-MC-O016
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The mean change in heart rate (HR)

  The mean change in HR

  Day 1: Hour 1, Hour 4 post intervention

Study Arms (3)

Wearable Biosensor Patch Device + Propranolol

EXPERIMENTAL

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

Drug: Propranolol; Device: Wearable Biosensor Patch Device

Wearable Biosensor Patch Device + Pseudoephedrine

EXPERIMENTAL

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

Drug: Pseudoephedrine; Device: Wearable Biosensor Patch Device

Wearable Biosensor Patch Device (Alone)

EXPERIMENTAL

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

Device: Wearable Biosensor Patch Device

Interventions

Propranolol DRUG

Administered orally.

Wearable Biosensor Patch Device + Propranolol

Pseudoephedrine DRUG

Administered orally.

Wearable Biosensor Patch Device + Pseudoephedrine

Wearable Biosensor Patch Device 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); Wearable Biosensor Patch Device + Propranolol; Wearable Biosensor Patch Device + Pseudoephedrine

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

Propranolol; Pseudoephedrine

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Phenethylamines; Ethylamines

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 23, 2020
• Study Start: January 27, 2021
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)