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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 mg single ascending dose (SAD) Group | Experimental | Participants receive a 6 mg single dose of GSK4024484, in a fasted state. |
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| 12 mg SAD Group | Experimental | Participants receive a 12 mg single dose of GSK4024484 in a fasted state. |
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| 24 mg SAD Group | Experimental | Participants receive a 24 mg single dose of GSK4024484 in a fasted state. |
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| 48 mg SAD Group | Experimental | Participants receive a 48 mg single dose of GSK4024484 in a fasted state. |
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| 96 mg SAD Group | Experimental | Participants receive a 96 mg single dose of GSK4024484 in a fasted state. |
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| 192 mg SAD Group | Experimental | Participants receive a 192 mg single dose of GSK4024484, in a fasted state. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK4024484C | Drug | Doses administrated orally with 240 mL of water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | CB2 0GG | United Kingdom |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| Food Effect Group | Experimental | Participants receive a single study dose of GSK4024484 in a fed state. |
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| 300 mg SAD Group | Experimental | Participants receive a 300 mg single dose of GSK4024484, in a fasted state. |
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| 400 mg SAD Group | Experimental | Participants receive a 400 mg single dose of GSK4024484, in a fasted state. |
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| Optional SAD Group | Experimental | 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. |
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| Placebo SAD Group | Placebo Comparator | Participants receive placebo in a fed or fasted state. |
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| 150 mg multiple ascending doses (MAD) Group | Experimental | Participants receive 150 mg per day of GSK4024484 during 3 subsequent days (450 mg total). |
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| 300 mg MAD Group | Experimental | Participants receive 300 mg per day of GSK4024484 during 3 subsequent days (900 mg total). |
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| Optional MAD Group | Experimental | 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. |
|
| Placebo MAD Group | Placebo Comparator | Participants receive placebo during 3 subsequent days. |
|
| Placebo | Drug | Doses administrated orally with 240 mL of water. |
|
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.
| 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. | 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. | 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. | 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. | From first study dose administration (Day 1) until the follow up contact (Day 40 +/- 3 days post dose) |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At Day 1 and at Day 3 |
| Part B: Observed accumulation ratio (R) of GSK4024484 based on Cmax(RCmax) following multiple ascending doses | At Day 1 and at Day 3 |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |