Asthma Clinical Trial
Official title:
An Open Label, Dose Escalation Study to Examine the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of Single and Repeat Oral Doses of GSK2190915 in Children Aged From 1 to 11 Years With Asthma
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.
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