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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
Doses administrated orally with 240 mL of water.
Doses administrated orally with 240 mL of water.
GSK Investigational Site
Cambridge, United Kingdom
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)
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)
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)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Time frame: 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
Mild AE = 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 AE = 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 AE = 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 study dose administration (Day 1) until the follow up contact (Day 38 +/- 3 days post dose)
Percentage of participants reporting non-serious AEs after multiple ascending doses
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 40 +/- 3 days post dose)
Percentage of participants reporting non-serious AEs by severity after multiple ascending doses
Mild AE = 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 AE = 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 AE = 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 first study dose administration (Day 1) until the follow up contact (Day 40 +/- 3 days post dose)
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)
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)
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)
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)
Part A: Apparent terminal half-life (t1/2) 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)
Part B: AUC(0-t) of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: AUC(0-∞) of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Cmax of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Tmax of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: t1/2 of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Area under the plasma drug concentration versus time curve from zero to time of trough plasma concentration [AUC(0-tau)] of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: Part B: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part B: Trough plasma concentration (Ctau) of GSK4024484C following multiple ascending doses in fasting conditions
Time frame: From first study dose administration (Day 1) until the follow up contact (Day 33 +/- 1 day post dose)
Part A: AUC(0-t) of GSK4024484C following single ascending doses in fed conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: AUC(0-∞) of GSK4024484C following single ascending doses in fed conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Cmax of GSK4024484C following single ascending doses in fed conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: Tmax of GSK4024484C following single ascending doses in fed conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part A: t1/2 of GSK4024484C following single ascending doses in fed conditions
Time frame: From study dose administration (Day 1) until the follow up contact (Day 29 +/- 1 day post dose)
Part B: Observed accumulation ratio (R) of GSK4024484 based on AUC(Ro) following multiple ascending doses
Time frame: At Day 1 and at Day 3
Part B: Observed accumulation ratio (R) of GSK4024484 based on Cmax(RCmax) following multiple ascending doses
Time frame: At Day 1 and at Day 3