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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects ≥4 and< 12 years. First 6 subjects included, ≥8 and< 12 yrs and weigh ≥21kg, receive 1 SD (10mg) and an 8 day RD period (100mg). Remaining subjects in cohort: Subjects < 21kg receive 2 SD periods (10mg and 50mg), Subjects > 21kg receive 2 SD periods (10mg and 50mg) and an 8 day RD (100mg) |
|
| Cohort 2 | Experimental | Subjects ≥1 and< 4 years, receive 2 SD (5mg and 25mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2190915A 5mg | Drug | Oral powder for dispersion in water |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Derived plasma pharmacokinetic parameters | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Leukotriene biomarkers | 24 hours | |
| Vital Signs | 24 hours | |
| ECG |
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Inclusion Criteria:
A signed and dated informed consent from at least one parent/guardian, and, for subjects ≥ 7 years old an accompanying informed assent from the subject prior to admission to the study.
- AST and ALT < 2xULN.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| GSK2190915A 10mg |
| Drug |
Oral powder for dispersion in water |
|
| GSK2190915A 25mg | Drug | Oral powder for dispersion in water |
|
| GSK2190915A 50mg | Drug | Oral powder for dispersion in water |
|
| GSK2190915A 100mg | Drug | Oral powder for dispersion in water |
|
| 24 hours |
| Adverse Event Monoitoring | Up to 90 days |
| Clinical Labs | 24 hours |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |