A Study of Continuous Blood Pressure Monitoring in Healthy Participants

Lilly

Status: Completed

Conditions: Healthy

Treatments: Other: No Intervention; Drug: Propranolol; Drug: Pseudoephedrine; Device: ABPM and Wearable Novel Devices

Study type: Interventional

Funder types: Industry

Identifiers

NCT05692869

H6O-MC-O017 (Other Identifier)

18655

Details and patient eligibility

About

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.

Enrollment: 24 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
• Regular use of 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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24 participants in 3 patient groups

ABPM + Wearable Novel Devices + Propranolol

Experimental group

Description:

Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) with propranolol administered orally for 5 days in one of three study periods.

Treatment:

Device: ABPM and Wearable Novel Devices

Drug: Propranolol

ABPM + Wearable Novel Devices + Pseudoephedrine

Experimental group

Description:

Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) with pseudoephedrine administered orally for 5 days in one of three study periods.

Treatment:

Device: ABPM and Wearable Novel Devices

Drug: Pseudoephedrine

ABPM + Wearable Novel Devices Only

Experimental group

Description:

Participants will wear all the devices (ABPM, chest patch device, wrist device and smartwatch device) during one of three study periods.

Treatment:

Device: ABPM and Wearable Novel Devices

Other: No Intervention