Investigating the safety of GSK4024484 in healthy adults

A Phase 1, Randomised, Double Blind Placebo-controlled, First Time in Human Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Oral Doses and Food Effect of GSK4024484 in Healthy Adult Participants.

This study is testing a new medication called GSK4024484 in healthy adults to see if it is safe before it is used in people with malaria.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: GlaxoSmithKline (Industry-sponsored)
• Locations: 1 site (Cambridge)
• Trial ID: NCT06171113 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety of GSK4024484, a new medication, in healthy adult participants. It will involve administering the drug and a placebo to assess pharmacokinetics and monitor any adverse effects. Participants will undergo medical evaluations, including physical exams and laboratory tests, to ensure they meet health criteria. The study is designed to gather important safety data before further testing in individuals with malaria.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 60 who meet specific health criteria.

Not a fit: Patients with significant health issues or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the development of a safe and effective treatment for malaria.

How similar studies have performed: Other studies have shown success in evaluating safety for new malaria treatments, but this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

1. Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent.
2. Participants who are considered healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac assessment.
3. A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, or outside the normal reference range for the population being studied, may be included only if the Investigator considers, that the finding is unlikely to introduce additional risk factors for the participant and will not interfere with the study procedures or endpoints.
4. ALT (Alanine transaminase) and AST (Aspartate transaminase) within the normal range at screening.
5. Total bilirubin within the normal range unless the participant is known to have Gilbert's syndrome.
6. Body weight ≥50kg, and BMI within the range 19 to 32 kilogram per square metre (kg/m\^2) inclusive.
7. Male participants and female participants who are not of child bearing potential.
8. The participant is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion Criteria:

1. 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.
2. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
3. 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.
4. QTcF (Fridericia's formula) \>450 msec based on average of triplicate ECGs. The QTcF is the QT interval corrected for heart rate according to QTcF.
5. More than 100 ventricular ectopic complexes in 24 hrs by Holter screening or any other clinically significant Holter abnormalities determined by the investigator.
6. Presence or history of cardiac arrhythmias or cardiac disease or a family or personal history of long QT syndrome.
7. Heart rate \<40 or \>100 beats per minute (bpm).
8. Evidence of previous myocardial infarction or any clinically significant conduction abnormality such as (including but not specific to left complete bundle branch block, AV block \[2nd degree or higher\], WPW syndrome). Long standing RBBB is permitted.
9. Past or intended use of over-the-counter or prescription medication, including herbal medications, CBD-based products, PPIs or H2 antagonists within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is the longest) prior to dosing. Other concomitant medication may be considered on a case by case basis by the investigator in consultation with the medical monitor. Paracetamol is permitted (capped at ≤2 grams/day).
10. Participation in the study that would result in loss of blood or blood products in excess of 500 mL within a 56-day period.
11. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
12. Current enrolment or past participation (within the last 30 days before planned first dose in this study) in any other clinical study involving an investigational study intervention or any other type of medical research.
13. Participants previously dosed in this study.
14. Presence of HBsAg \[or HBcAb\] at screening or within 3 months prior to first dose of study intervention.
15. Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
16. Positive hepatitis C RNA (ribonucleic acid) test result at screening or within 3 months prior to first dose of study intervention.
17. Positive pre-study drug/alcohol screen.
18. Positive HIV antibody test.
19. Carbon monoxide levels indicative of smoking or more than 10 pack year history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
20. Use of known recreational drugs or drugs of abuse.
21. Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates participation in the study.
22. A positive confirmation of COVID-19 infection according to local procedures.

Where this trial is running

Cambridge

• GSK Investigational Site — Cambridge, United Kingdom (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions Malaria, Falciparum; First time in human; Safety; Pharmacokinetics; GSK4024484; Healthy adults; Food effect; Single oral doses