A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants
ConditionMalaria, Falciparum
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorGlaxoSmithKline
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Disqualifiers
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/m²) inclusive.
Male participants and female participants who are not of child bearing potential.
Trial design
Design model
Sequential
Treatments tested in this trial
GSK4024484C
DrugDoses administrated orally with 240 mL of water.
Placebo
DrugDoses administrated orally with 240 mL of water.
Treatment groups
156 Participants
are divided into 15 treatment groups15
Treatment groupsSee each treatment group below.
Group A: 6 mg single ascending dose (SAD) GroupExperimental treatment 1 intervention
Group B: 12 mg SAD GroupExperimental treatment 1 intervention
Group C: 24 mg SAD GroupExperimental treatment 1 intervention
Group D: 48 mg SAD GroupExperimental treatment 1 intervention
Group E: 96 mg SAD GroupExperimental treatment 1 intervention
Group F: 192 mg SAD GroupExperimental treatment 1 intervention
Group G: Food Effect GroupExperimental treatment 1 intervention
Group H: 300 mg SAD GroupExperimental treatment 1 intervention
Group I: 400 mg SAD GroupExperimental treatment 1 intervention
Group J: Optional SAD GroupExperimental treatment 1 intervention
Group K: Placebo SAD GroupPlacebo comparator 1 intervention
Group L: 150 mg multiple ascending doses (MAD) GroupExperimental treatment 1 intervention
Group M: 300 mg MAD GroupExperimental treatment 1 intervention
Group N: Optional MAD GroupExperimental treatment 1 intervention
Group O: Placebo MAD GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants reporting serious adverse events (SAEs) after single ascending doses
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal partner pregnancy outcome.
Time frame
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
Mild SAE = a type of adverse event (AE) that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate SAE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe SAE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Time frame
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
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or an abnormal partner pregnancy outcome.
Time frame
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
Mild SAE = a type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate SAE = a type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Severe SAE = a type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Time frame
From the signing of the informed consent (Day -2) until the follow up contact (Day 40 +/- 3 days post dose)Secondary outcomes
1
Part A: Area under the plasma drug concentration versus time curve from time zero (pre-dose) to last time of quantifiable concentration [AUC(0-t)] of GSK4024484C following single ascending doses in fasting conditions
Time frame
From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)2
Part A: Area under the plasma drug concentration versus time curve from zero (pre-dose) extrapolated to infinite time [AUC(0-∞)] of GSK4024484C following single ascending doses in fasting conditions
Time frame
From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)3
Part A: Maximum observed plasma drug concentration (Cmax) of GSK4024484C following single ascending doses in fasting conditions
Time frame
From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)4
Part A: Time to maximum observed plasma drug concentration (Tmax) of GSK4024484C following single ascending doses in fasting conditions
Time frame
From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)Sponsors and contacts
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Source ClinicalTrials.gov