A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants (NCT06171113) | Clinical Trial Compass
RecruitingPhase 1
A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
United Kingdom156 participantsStarted 2023-12-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent.
. Participants who are considered healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac assessment.
Exclusion criteria
. ALT (Alanine transaminase) and AST (Aspartate transaminase) within the normal range at screening.
. Total bilirubin within the normal range unless the participant is known to have Gilbert's syndrome.
. Body weight ≥50kg, and BMI within the range 19 to 32 kilogram per square metre (kg/m\^2) inclusive.
. Male participants and female participants who are not of child bearing potential.
. The participant is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
. History or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data in the opinion of the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants reporting serious adverse events (SAEs) after single ascending doses
Timeframe: From the signing of the informed consent (Day -2) until the follow up contact (Day 38 +/- 3 days post dose)
2
Percentage of participants reporting SAEs by severity after single ascending doses
Timeframe: From the signing of the informed consent (Day -2) until the follow up contact (Day 38 +/- 3 days post dose)
3
Percentage of participants reporting SAEs after multiple ascending doses
Timeframe: From the signing of the informed consent (Day -2) until the follow up contact (Day 40 +/- 3 days post dose)
4
Percentage of participants reporting SAEs by severity after multiple ascending doses
Timeframe: From the signing of the informed consent (Day -2) until the follow up contact (Day 40 +/- 3 days post dose)
5
Percentage of participants reporting non-serious AEs after single ascending doses
Timeframe: From study dose administration (Day 1) until the follow up contact (Day 38 +/- 3 days post dose)
6
Percentage of participants reporting non-serious AEs by severity after single ascending doses
. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
. An average weekly alcohol intake of \>14 units a week within 6 months prior to the study. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
Timeframe: From study dose administration (Day 1) until the follow up contact (Day 38 +/- 3 days post dose)
7
Percentage of participants reporting non-serious AEs after multiple ascending doses
Timeframe: From first study dose administration (Day 1) until the follow up contact (Day 40 +/- 3 days post dose)
8
Percentage of participants reporting non-serious AEs by severity after multiple ascending doses
Timeframe: From first study dose administration (Day 1) until the follow up contact (Day 40 +/- 3 days post dose)