drugset / Trial / NCT01286844
GSK2190915 Pediatric Study
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2010-11
- Primary completion
- 2011-05
- Completion
- 2011-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FIBOFLAPON | Small molecule | 5 mg | Oral |
| Subject | FIBOFLAPON | Small molecule | 10 mg | Oral |
| Subject | FIBOFLAPON | Small molecule | 25 mg | Oral |
| Subject | FIBOFLAPON | Small molecule | 50 mg | Oral |
| Subject | FIBOFLAPON | Small molecule | 100 mg | Oral |