Last updated: 11/03/2018 12:57:37
GSK2190915 Pediatric study
GSK study ID
112361
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Derived plasma pharmacokinetic parameters
Timeframe: 24 hours
Secondary outcomes:
Leukotriene biomarkers
Timeframe: 24 hours
Vital Signs
Timeframe: 24 hours
ECG
Timeframe: 24 hours
Adverse Event Monoitoring
Timeframe: Up to 90 days
Clinical Labs
Timeframe: 24 hours
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fiboflapon
Collaborators
Not applicable
Study date(s)
November 2010 to May 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
1 - 11 years
Accepts healthy volunteers
No
- Male and pre-menarchial female subjects aged 1to <12 years at screening are eligible for this study.
- Investigator diagnosed history of asthma.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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