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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06625489 | A Study to Evaluate the Safety, Tolerability and Blood Levels of GSK3915393 Administered to Healthy Participants of Chinese, Japanese and European Ancestry and to Assess Effects of GSK3915393 on Nintedanib | PHASE1 | COMPLETED | 50 | — | — | Oct 7, 2024 | Nov 25, 2024 | Feb 18, 2025 | 2 | United States |
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.
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: results in death; is life threatening; requires 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; abnormal pregnancy outcome; or is a suspected transmission of any infectious agent via an authorized medicinal product.
Number of participants with clinically significant changes in clinical laboratory values (hematology, clinical chemistry, and routine urinalysis) will be assessed.
Number of participants with clinically significant changes in Vital signs (temperature, systolic and diastolic blood pressure \[BP\], pulse rate and respiratory rate \[RR\]) will be assessed.
Number of participants with clinically significant changes in 12-lead ECG will be assessed.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate time of maximum plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
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
| Arm | Type | Description |
|---|---|---|
| Part A: GSK3915393 | EXPERIMENTAL | Participants from Chinese, Japanese, and European ancestries will be randomized to receive GSK3915393 under fasting condition. |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants from Chinese, Japanese, and European ancestries will be randomized to receive placebo under fasting condition. |
| Part B: Nintedanib followed by Nintedanib plus GSK3915393 | EXPERIMENTAL | Male participants will be randomized to receive Nintedanib in Period 1 followed by co-administration of Nintedanib and GSK3915393 in Period 2 under fed conditions. There will be a washout period of minimum 5 days post last dose between Period 1 and Period 2. |
| Part B: Nintedanib plus GSK3915393 followed by Nintedanib | EXPERIMENTAL | Male participants will be randomized to receive co-administration of Nintedanib and GSK3915393 in Period 1 followed by Nintedanib in Period 2 under fed conditions. There will be a washout period of minimum 5 days post last dose between Period 1 and Period 2. |
| Name | Type | Description |
|---|---|---|
| Part A: Placebo | DRUG | Placebo will be administered. |
| Nintedanib | DRUG | Nintedanib will be administered. |
| GSK3915393 | DRUG | GSK3915393 will be administered. |
Inclusion Criteria: For Part A and Part B: Participants who are generally healthy as determined by medical evaluation based on screening medical history, physical examination, vital signs, electrocardiogram (ECG) assessments, and laboratory tests Body weight at least 50.0 kilograms (kg) (110 pound...
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