GSK2190915 is under development as an oral controller for the treatment of adult and pediatric asthma. This study is an open label, single and repeat dose escalation study, in children with asthma. It will investigate the pharmacokinetics of GSK2190915 in children, aged from 1 to 12 years old inclusive, to determine how the dosage regimen for GSK2190915 in a pediatric population should be adjusted to achieve approximately the same level of systemic exposure that is safe and effective in adults.
Subjects will be recruited into 2 cohorts, Cohort 1 with children from 4 years of age to less than 12 years of age and cohort 2 with children from 1 year of age to less than 4 years of age. Cohort 1 is further subdivided, dependent on a subject's weight, which enables different dosing regimens and pharmacokinetic sampling within the cohort. There are 3 scheduled Pharmacokinetic and Safety Review meetings, which enable dose adjustment and dosing in the younger subjects through the study. Blood and urine are collected for pharmacokinetic and pharmacodynamic analysis. Safety will be assessed by measurement of heart rate, blood pressure, ECG, safety laboratory data and review of adverse events. Subjects will also perform PEF and Spirometry if assessed as capable by the study investigator.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Oral powder for dispersion in water
Oral powder for dispersion in water
Oral powder for dispersion in water
Derived plasma pharmacokinetic parameters
Time frame: 24 hours
Leukotriene biomarkers
Time frame: 24 hours
Vital Signs
Time frame: 24 hours
ECG
Time frame: 24 hours
Adverse Event Monoitoring
Time frame: Up to 90 days
Clinical Labs
Time frame: 24 hours
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Oral powder for dispersion in water
Oral powder for dispersion in water