HealthyNCT04682184
A Study of Continuous Heart Rate Monitoring in Healthy Participants
A study testing Propranolol, Pseudoephedrine and Wearable Biosensor Patch Device in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Propranolol, Pseudoephedrine and Wearable Biosensor Patch Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Jan 2021to 25 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Propranolol, Pseudoephedrine, Wearable Biosensor Patch Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Administered orally.
PseudoephedrineDrug
Administered orally.
Wearable Biosensor Patch DeviceDevice
Biosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Biosensor Patch Device + Propranolol | Experimental | Participants will wear the biosensor patch device followed by propranolol administered orally in one of three study periods. Receives: 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. Receives: 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. Receives: Device: Wearable Biosensor Patch Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in heart rate (HR)
The mean change in HR
Measured: Day 1: Hour 1, Hour 4 post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start27 Jan 2021
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682184
- Sponsor's protocol ID
- 18168
- Other IDs
- H6O-MC-O016
- Status last verified
- Apr 2021
- First submitted
- 10 Dec 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04682184
- Acronym / sponsor ID
- 18168
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wearable Biosensor Patch Device + Propranolol | Experimental | Drug: Propranolol, Device: Wearable Biosensor Patch DeviceParticipants will wear the biosensor patch device followed by propranolol administered orally in one of three study periods. |
| Wearable Biosensor Patch Device + Pseudoephedrine | Experimental | Drug: Pseudoephedrine, Device: Wearable Biosensor Patch DeviceParticipants will wear the biosensor patch device followed by pseudoephedrine administered orally in one of three study periods. |
| Wearable Biosensor Patch Device (Alone) | Experimental | Device: Wearable Biosensor Patch DeviceParticipants will wear biosensor patch device (alone) during one of three study periods. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololAdministered orally. | Drug | Wearable Biosensor Patch Device + Propranolol |
| PseudoephedrineAdministered orally. | Drug | Wearable Biosensor Patch Device + Pseudoephedrine |
| Wearable Biosensor Patch DeviceBiosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days. | Device | Wearable Biosensor Patch Device (Alone), Wearable Biosensor Patch Device + Propranolol, Wearable Biosensor Patch Device + Pseudoephedrine |
Primary outcome
The mean change in heart rate (HR)
Time frame: Day 1: Hour 1, Hour 4 post intervention
The mean change in HR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propranolol, Pseudoephedrine and Wearable Biosensor Patch Device in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in heart rate (HR) (time frame: Day 1: Hour 1, Hour 4 post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.