GSK2190915 Pediatric Study

NCT01286844 | Withdrawn Phase 2

• 1 other identifier: 112361
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Asthma

Outcome Measures

Primary Outcomes (1)

• Derived plasma pharmacokinetic parameters

  24 hours

Secondary Outcomes (5)

• Leukotriene biomarkers

  24 hours

• Vital Signs

  24 hours

• ECG

  24 hours

• Adverse Event Monoitoring

  Up to 90 days

• Clinical Labs

  24 hours

Study Arms (2)

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)

Drug: GSK2190915A 10mg; Drug: GSK2190915A 50mg; Drug: GSK2190915A 100mg

Cohort 2

EXPERIMENTAL

Subjects ≥1 and\< 4 years, receive 2 SD (5mg and 25mg)

Drug: GSK2190915A 5mg; Drug: GSK2190915A 25mg

Interventions

GSK2190915A 5mg DRUG

Oral powder for dispersion in water

Cohort 2

GSK2190915A 10mg DRUG

Oral powder for dispersion in water

Cohort 1

GSK2190915A 25mg DRUG

Oral powder for dispersion in water

Cohort 2

GSK2190915A 50mg DRUG

Oral powder for dispersion in water

Cohort 1

GSK2190915A 100mg DRUG

Oral powder for dispersion in water

Cohort 1

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and pre-menarchial female subjects aged 1to \<12 years at screening are eligible for this study.
• Investigator diagnosed history of asthma.
• Subject weight a minimum of 11kg and above the 10th percentile for their age.
• Patients must be controlled on any existing asthma treatment or currently stable off treatment, at screening.
• Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from no other significant medical conditions.
• Subjects and parents/guardians must be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. Parents/guardians must have the ability to read and write.
• 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.

You may not qualify if:

• Subjects who have changed their asthma medication, dose or regime within 4 weeks of screening
• Administration of anti -leukotriene therapies for 14 days before screening and during the study.
• Any medical condition or circumstance making the volunteer unsuitable for participation in the study.
• Any clinically relevant abnormality identified on the screening medical assessment.
• Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening and led to a change in asthma management.
• Administration of any vaccinations within 2 weeks of screening or during the study
• Parent/guardian has history of psychiatric disease, intellectual deficiency, substance abuse, or other condition which will limit the validity of consent to participate in this study.
• Any adverse reaction including immediate or delayed hypersensitivity to any component of study drug
• A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.
• Children who are wards of the state or government.
• The subject has a screening QTc value of \>450msec, PR interval outside the range 120 to 220msec or an ECG that is not suitable for QT measurements.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: January 31, 2011
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 7, 2017

Record last verified: 2017-06