GSK3915393 is a new medicine which is being developed for a chronic lung disease called Idiopathic Pulmonary Fibrosis (IPF). This is a healthy participant study which has two parts. Part A will assess the safety, tolerability, and blood levels of GSK3915393 given as a single dose to healthy participants of Chinese, Japanese, and European ancestries. Part B is a drug-drug interaction (DDI) study that examines the effect of a single dose of GSK3915393 on the blood levels of a single dose of nintedanib, which is an approved drug for IPF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Placebo will be administered.
Nintedanib will be administered.
GSK3915393 will be administered.
GSK Investigational Site
Cypress, California, United States
GSK Investigational Site
Las Vegas, Nevada, United States
Part A: Number of Participants with Adverse Events (AEs)
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: Up to Day 10
Part A: Number of Participants with Serious Adverse Events (SAEs)
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.
Time frame: Up to Day 10
Part A: Number of Participants with Clinically Significant Changes in Clinical Laboratory Values
Number of participants with clinically significant changes in clinical laboratory values (hematology, clinical chemistry, and routine urinalysis) will be assessed.
Time frame: Up to Day 10
Part A: Number of Participants with Clinically Significant Changes in Vital Signs
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.
Time frame: Up to Day 10
Part A: Number of Participants with Clinically Significant Changes in 12-Lead Electrocardiogram (ECG)
Number of participants with clinically significant changes in 12-lead ECG will be assessed.
Time frame: Up to Day 10
Part A: Area Under the Plasma Concentration Versus Time Curve From Time Zero To t (AUC [0-t]) of GSK3915393
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Time frame: Up to 36 hours post dose
Part A: Area Under the Plasma Concentration Versus Time Curve From Time Zero To Infinity (AUC [0-inf]) of GSK3915393
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Time frame: Up to 36 hours post dose
Part A: Maximum Observed Plasma Concentration (Cmax) of GSK3915393
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Time frame: Up to 36 hours post dose
Part A: Time to Cmax (Tmax) of GSK3915393
Blood sample will be collected to evaluate time of maximum plasma concentration of GSK3915393.
Time frame: Up to 36 hours post dose
Part A: Apparent Terminal Half-life (T1/2) of GSK3915393
Blood sample will be collected to evaluate plasma concentration of GSK3915393.
Time frame: Up to 36 hours post dose
Part B: AUC (0-t) of Nintedanib
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
Time frame: Up to 48 hours post dose
Part B: AUC (0-inf) of Nintedanib
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
Time frame: Up to 48 hours post dose
Part B: Cmax 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
Time frame: Up to 48 hours post dose
Part B: Number of Participants with AEs
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.
Time frame: Up to Day 17
Part B: Number of Participants with SAEs
Number of participants with clinically significant changes in clinical laboratory values (hematology, clinical chemistry, and routine urinalysis) will be assessed.
Time frame: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in Clinically Laboratory Values
Number of participants with clinically significant changes in vital signs (temperature, systolic and diastolic BP, pulse rate and RR) will be assessed.
Time frame: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in 12-lead ECG will be assessed.
Time frame: Up to Day 17
Part B: Number of Participants with Clinically Significant Changes in 12-Lead ECG
Blood sample will be collected to evaluate the time of maximum plasma concentration of Nintedanib.
Time frame: Up to Day 17
Part B: Tmax of Nintedanib
Blood sample will be collected to evaluate plasma concentration of Nintedanib.
Time frame: Up to 48 hours post dose
Part B: T1/2 of Nintedanib
Time frame: Up to 48 hours post dose
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