Healthy
Conditions
Brief summary
The main purpose of this study in healthy participants is to find out whether the traditional ambulatory blood pressure monitor (ABPM) and newer wearable devices (EmbracePlus smartwatch device, Biobeat chest patch device, and Aktiia wrist device) will accurately pick up changes in blood pressure caused by 2 different medications (propranolol and pseudoephedrine). The study will last about 29 days excluding the screening period of 28 days.
Interventions
DRUGPropranolol
Administered orally.
DRUGPseudoephedrine
Administered orally.
DEVICEABPM and Wearable Novel Devices
ABPM and wearable novel devices including chest patch device, wrist device and smartwatch device worn throughout the trial.
OTHERNo Intervention
No intervention during this period (Control Period)
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 * Regular use of 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 Systolic Blood Pressure (SBP) Using Chest Patch Device | Baseline through 48 hours | The Mean Change in SBP Using Chest Patch Device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Change in Diastolic Blood Pressure (DBP) Using Chest Patch Device and Wrist Device | Baseline through 48 hours | The Mean Change in DBP Using Chest Patch Device and Wrist Device |
| The Mean Change in SBP Using Chest Patch Device and Wrist Device | Baseline through 120 hours | The Mean Change in SBP Using Chest Patch Device and Wrist Device |
| The Mean Change in SBP Using Wrist Device | Baseline through 48 hours | The Mean Change in SBP Using Wrist Device |
| The Mean Change in SBP Using Chest Patch Device, Wrist Device and ambulatory blood pressure monitor (ABPM) | Baseline through 48 hours | The Mean Change in SBP Using Chest Patch Device, Wrist Device and ABPM |
| The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM | Baseline through 48 hours | The Mean Change in DBP Using Chest Patch Device, Wrist Device and ABPM |
| The Mean Change in DBP Using Chest Patch Device and Wrist Device | Baseline through 120 hours | The Mean Change in DBP Using Chest Patch Device and Wrist Device |
Countries
Singapore
Outcome results
None listed