Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06171113 | A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants | PHASE1 | RECRUITING | 156 | — | — | Dec 11, 2023 | Aug 7, 2026 | Apr 1, 2026 | 1 | United Kingdom |
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.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 6 mg single ascending dose (SAD) Group | EXPERIMENTAL | Participants receive a 6 mg single dose of GSK4024484, in a fasted state. |
| 12 mg SAD Group | EXPERIMENTAL | Participants receive a 12 mg single dose of GSK4024484 in a fasted state. |
| 24 mg SAD Group | EXPERIMENTAL | Participants receive a 24 mg single dose of GSK4024484 in a fasted state. |
| 48 mg SAD Group | EXPERIMENTAL | Participants receive a 48 mg single dose of GSK4024484 in a fasted state. |
| 96 mg SAD Group | EXPERIMENTAL | Participants receive a 96 mg single dose of GSK4024484 in a fasted state. |
| 192 mg SAD Group | EXPERIMENTAL | Participants receive a 192 mg single dose of GSK4024484, in a fasted state. |
| Food Effect Group | EXPERIMENTAL | Participants receive a single study dose of GSK4024484 in a fed state. |
| 300 mg SAD Group | EXPERIMENTAL | Participants receive a 300 mg single dose of GSK4024484, in a fasted state. |
| 400 mg SAD Group | EXPERIMENTAL | Participants receive a 400 mg single dose of GSK4024484, in a fasted state. |
| 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. |
| Placebo SAD Group | PLACEBO_COMPARATOR | Participants receive placebo in a fed or fasted state. |
| 150 mg multiple ascending doses (MAD) Group | EXPERIMENTAL | Participants receive 150 mg per day of GSK4024484 during 3 subsequent days (450 mg total). |
| 300 mg MAD Group | EXPERIMENTAL | Participants receive 300 mg per day of GSK4024484 during 3 subsequent days (900 mg total). |
| 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. |
| Name | Type | Description |
|---|---|---|
| GSK4024484C | DRUG | Doses administrated orally with 240 mL of water. |
| Placebo | DRUG | Doses administrated orally with 240 mL of water. |
Inclusion Criteria: 1. Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent. 2. Participants who are considered healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac assessment. 3. A par...