Actively Recruiting
A Phase 1, Randomised, Double Blind Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Food Effect of Single and Multiple Oral Doses of GSK4024484 in Healthy Adults
Led by GlaxoSmithKline · Updated on 2026-04-01
156
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and pharmacokinetics of GSK4024484, a drug given orally, in healthy adult volunteers aged 18 to 60 years. This phase 1 study aims to understand how the drug behaves in the body within controlled dose ranges and to assess the effect of food on the drug's absorption and action. The study includes both single and multiple doses of GSK4024484 as well as placebo comparisons to monitor safety and reactions. Participants receive various single oral doses of GSK4024484 ranging from 6 mg up to 400 mg, all administered with 240 mL of water in a fasting state, with one group receiving a dose in a fed state to test food effects. There are also groups receiving multiple ascending doses over three days (150 mg or 300 mg per day) and corresponding placebo groups. Some optional dose groups allow adjustments if dose escalation needs modification or repetition. During the study, participants undergo medical evaluations including physical exams, laboratory tests, cardiac assessments, and monitoring for adverse events. Researchers track serious and non-serious side effects from the time of informed consent through follow-up days extending up to around 38 to 40 days post-dose. Pharmacokinetic measures such as drug concentration in blood over time and half-life are also recorded to understand how the drug is processed. The total participation time covers initial dosing through follow-up contacts to ensure safety and gather data.
CONDITIONS
Brief Title
A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years inclusive at the time of informed consent
- Considered healthy based on medical history, physical exam, lab tests, and cardiac assessment
- ALT and AST liver enzymes within normal range at screening
- Total bilirubin within normal range unless diagnosed with Gilbert's syndrome
- Body weight at least 50 kg with a BMI between 19 and 32 kg/m² inclusive
- Male participants and females not of childbearing potential
- Able to understand and follow study instructions and restrictions
You will not qualify if you...
- History or presence of significant cardiovascular, respiratory, liver, kidney, gastrointestinal, endocrine, hematologic, or neurological disorders
- Current or chronic liver disease or known liver/biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones)
- Average alcohol intake over 14 units per week in the past 6 months
- QTcF greater than 450 msec based on ECG
- More than 100 ventricular ectopic complexes in 24 hours or other significant Holter abnormalities
- History of cardiac arrhythmias, cardiac disease, or long QT syndrome
- Heart rate below 40 or above 100 beats per minute
- Evidence of previous heart attack or significant conduction abnormalities
- Use of medications including herbal or CBD products within 7 to 14 days before dosing (paracetamol up to 2 grams/day allowed)
- Blood loss exceeding 500 mL in the past 56 days
- Exposure to more than 4 new chemical entities in the past 12 months
- Enrollment in other clinical studies within 30 days before dosing
- Previous participation in this study
- Positive tests for Hepatitis B, Hepatitis C, HIV, or drug/alcohol use
- Smoking history over 10 pack-years or regular tobacco/nicotine use in last 6 months
- Use of recreational drugs or drugs of abuse
- Allergy or sensitivity to study treatments or components
- Positive COVID-19 infection confirmed by local testing procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 3 days depending on dose group
Participants receive single or multiple oral doses of the study drug or placebo in fasted or fed states as part of the dose escalation study.
1 dosing visit and multiple assessment visits over several days
Duration - Up to 40 days after dosing
Participants are monitored for safety and pharmacokinetics after dosing, including assessment of adverse events and drug levels.
Regular follow-up visits until Day 38 to Day 40 post dose
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
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
15
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