A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
NCT ID: NCT06171113
Last Updated: 2024-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
144 participants
INTERVENTIONAL
2023-12-12
2025-08-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Single-Blind, Placebo-Controlled, Randomized Study Testing Single Ascending Doses Of GSK369796 In Healthy Subjects
NCT00675064
A Study to Determine Whether 2 Investigational Malaria Vaccines Are Safe, Protective Against Malaria in Adults
NCT00385047
A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat Malaria
NCT00811356
A Study Of Zy-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects
NCT05206201
Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) to Evaluate the Safety and Efficacy of the Plasmodium Falciparum Vaccine Candidate FMP012 Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults
NCT02174978
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
6 mg single ascending dose (SAD) Group
Participants receive a 6 mg single dose of GSK4024484 or matching placebo, in a fasted state.
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
12 mg SAD Group
Participants receive a 12 mg single dose of GSK4024484 or matching placebo, in a fasted state.
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
24 mg SAD Group
Participants receive a 24 mg single dose of GSK4024484 or matching placebo, in a fasted state.
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
40 mg SAD Group
Participants receive a 40 mg single dose of GSK4024484 or matching placebo, in a fasted state.
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
60 mg SAD Group
Participants receive a 60 mg single dose of GSK4024484 or matching placebo, in a fasted state.
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
80 mg SAD Group
Participants receive a 80 mg single dose of GSK4024484 or matching placebo, in a fasted state.
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
Food Effect Group
Participants receive a single study dose of either GSK4024484 or matching placebo in a fed state.
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
100 mg SAD Group
Participants receive a 100 mg single dose of GSK4024484 or matching placebo.
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
Optional Group
Participants may be included in this group, to allow flexibility if the dose escalation needs modification or a dose level needs to be added or repeated.
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
10 mg multiple ascending doses (MAD) Group
Participants receive a single dose of 10 mg per day of GSK4024484 or matching placebo during 3 subsequent days (30 mg total).
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
20 mg MAD Group
Participants receive a single dose of 20 mg per day of GSK4024484 or matching placebo during 3 subsequent days (60 mg total).
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
30 mg MAD Group
Participants receive a single dose of 30 mg per day of GSK4024484 or matching placebo during 3 subsequent days (90 mg total).
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GSK4024484C
Doses administrated orally with 240 mL of water.
Placebo
Doses administrated orally with 240 mL of water.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participants who are considered healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac assessment.
Exclusion Criteria
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.
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.
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medicines for Malaria Venture
OTHER
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Unit Cambridge (Cuc)-Cambridge-United Kingdom-C
Cambridge, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
218708
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.