Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT04682184
  4. Details
NCT04682184 Clinical Trial

A Study of Continuous Heart Rate Monitoring in Healthy Participants

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04682184
Other study ID # 18168
Secondary ID H6O-MC-O016
Status Completed
Phase N/A
First received
Last updated
Start date January 27, 2021
Est. completion date March 25, 2021

Study information
Verified date April 2021
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date March 25, 2021
Est. primary completion date March 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propranolol
Administered orally.
• Pseudoephedrine
Administered orally.
Device:
• Wearable Biosensor Patch Device
Biosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days.

Locations
Country Name City State
Singapore Lilly Centre for Clinical Pharmacology Singapore

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary The mean change in heart rate (HR) The mean change in HR Day 1: Hour 1, Hour 4 post intervention
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1