Actively Recruiting
A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
Led by GlaxoSmithKline · Updated on 2026-04-01
156
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary purpose of the study is to characterise the safety of GSK4024484 in healthy participants within a controlled pharmacokinetic (PK) range, and the effect of food on the study intervention.
CONDITIONS
Official Title
A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years inclusive at the time of consent
- Healthy as confirmed by medical history, physical exam, lab tests, and cardiac assessment
- Clinical abnormalities not listed in criteria may be allowed if judged safe by the investigator
- ALT and AST liver enzymes within normal range at screening
- Total bilirubin within normal range unless participant has Gilbert's syndrome
- Body weight at least 50 kg and BMI between 19 and 32 kg/m² inclusive
- Male participants and females who are not of childbearing potential
- Able to understand and follow study instructions and requirements
You will not qualify if you...
- History or presence of serious cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, blood, or neurological disorders
- Current or chronic liver disease or known biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones)
- Average alcohol intake over 14 units per week in the last 6 months
- QTcF interval over 450 msec on ECG
- More than 100 ventricular ectopic complexes in 24 hours or other significant Holter abnormalities
- History or presence of cardiac arrhythmias, cardiac disease, or family/personal history of long QT syndrome
- Heart rate below 40 or above 100 beats per minute
- Evidence of prior heart attack or significant conduction abnormalities (except long-standing right bundle branch block)
- Use of medications including herbal or CBD products within 7 days (or 14 days for enzyme inducers) before dosing, except paracetamol capped at 2 grams/day
- Blood loss exceeding 500 mL within 56 days prior to study
- Exposure to more than 4 new chemical entities within 12 months before dosing
- Current or recent participation (within 30 days) in other clinical studies involving investigational drugs
- Prior dosing in this study
- Positive tests for hepatitis B or C within 3 months before dosing
- Positive drug or alcohol screening before study
- Positive HIV antibody test
- Smoking history over 10 pack years or recent tobacco/nicotine use
- Use of recreational or abused drugs
- Known allergies or sensitivity to study drugs or components
- Positive COVID-19 infection confirmation according to local testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
GSK Investigational Site
Cambridge, United Kingdom, CB2 0GG
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
15
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here