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GSK2190915 Pediatric Study

NCT01286844 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-06-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

GSK2190915A 5mg

Oral powder for dispersion in water

DRUG

GSK2190915A 10mg

Oral powder for dispersion in water

DRUG

GSK2190915A 25mg

Oral powder for dispersion in water

DRUG

GSK2190915A 50mg

Oral powder for dispersion in water

DRUG

GSK2190915A 100mg

Oral powder for dispersion in water

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-05-31
Completion
2011-05-31

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01286844 on ClinicalTrials.gov