The purpose of this study is to evaluate how itraconazole affects the blood concentration of GSK3923868 in healthy adults.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
GSK3923868 will be administered.
Itraconazole will be administered.
GSK Investigational Site
Cambridge, United Kingdom
Treatment Period 1: Area under plasma concentration versus time curve (AUC) from time zero to last quantifiable concentration [AUC(0-t)] for GSK3923868 without itraconazole co-administration
Time frame: Up to Day 3
Treatment Period 2: AUC(0-t) for GSK3923868 with itraconazole co-administration
Time frame: Up to Day 11
Treatment Period 1: AUC from time zero to infinity [AUC(0-∞)] for GSK3923868 without itraconazole co-administration
Time frame: Up to Day 3
Treatment Period 2: AUC(0-∞) for GSK3923868 with itraconazole co-administration
Time frame: Up to Day 11
Treatment Period 1: Maximum observed plasma concentration (Cmax) for GSK3923868 without itraconazole co-administration
Time frame: Up to Day 3
Treatment Period 2: Cmax for GSK3923868 with itraconazole co-administration
Time frame: Up to Day 11
Treatment Period 1: Time to Cmax (Tmax) for GSK3923868 without itraconazole co-administration
Time frame: Up to Day 3
Treatment Period 2: Tmax for GSK3923868 with itraconazole co-administration
Time frame: Up to Day 11
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.
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Time frame: Up to Day 30
Number of participants with serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose, 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, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product.
Time frame: Up to Day 30
Number of participants with clinically significant changes in laboratory values
Time frame: Up to Day 30
Number of participants with clinically significant changes in vital signs
Time frame: Up to Day 30
Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) measurements
Time frame: Up to Day 30
Treatment Period 2: AUC(0-t) for itraconazole and hydroxy-itraconazole
Time frame: On Days 1 and 5
Treatment Period 2: AUC(0-∞) for itraconazole and hydroxy-itraconazole
Time frame: On Days 1 and 5
Treatment Period 2: Cmax for itraconazole and hydroxy-itraconazole
Time frame: On Days 1 and 5
Treatment Period 2: Tmax for itraconazole and hydroxy-itraconazole
Time frame: On Days 1 and 5