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 range18 Years – 60 Years

SexALL

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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.
✕. 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.

What they're measuring

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)

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)

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)

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)

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)

Percentage of participants reporting non-serious AEs by severity after single ascending doses

Timeframe: From study dose administration (Day 1) until the follow up contact (Day 38 +/- 3 days post dose)

Trial details

NCT IDNCT06171113

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-07

Contact for this trial

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

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