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Virus Therapy
Bepirovirsen's Effect on Heart Function
Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body weight >= 50 Kilograms (kg) and Body mass index (BMI) within the range 19-32 Kilograms per square meter (kg/m^2) (inclusive)
Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
Must not have
Regular use of known drugs of abuse, including tetrahydrocannabinol
Known history of heart disease, including various cardiac conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial will look at how a one-time dose of bepirovirsen affects the QT interval of the heart compared to a placebo. The goal is to understand the relationship between the concentration of be
Who is the study for?
This trial is for healthy volunteers who want to help test the effects of a drug called Bepirovirsen on heart function. Participants should not have any current health issues, especially related to hepatitis or heart conditions.
What is being tested?
The study is testing how a single dose of Bepirovirsen affects the electrical activity of the heart (QT interval) compared to a placebo. The results will help understand if there's any risk of abnormal heart rhythms.
What are the potential side effects?
Since this trial involves healthy volunteers, side effects are closely monitored but may include changes in heartbeat, mild discomfort at injection site, or other non-specific symptoms like headache or nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 50 kg and my BMI is between 19 and 32.
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I am between 18 and 55 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not use recreational drugs, including THC.
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I have a history of heart disease.
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I have not been exposed to more than 4 new drugs in the last year.
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I have tested positive for drugs or alcohol, including THC.
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I have had fainting spells or near fainting due to heart palpitations, or there's a family history of sudden heart-related deaths.
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I have used prescription, over-the-counter, or herbal medications within the last 7 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants receiving BepirovirsenExperimental Treatment1 Intervention
Group II: Participants receiving PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bepirovirsen
2023
Completed Phase 1
~160
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
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