Healthy
Conditions
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.
Interventions
DRUGPropranolol
Administered orally.
DRUGPseudoephedrine
Administered orally.
DEVICEWearable Biosensor Patch Device
Biosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean change in heart rate (HR) | Day 1: Hour 1, Hour 4 post intervention | The mean change in HR |
Countries
Singapore
Outcome results
None listed