Aura Adolescent PK Study GSK2829332
This is a randomized, double-blind, placebo-controlled, repeat dose, 2-period, incomplete block, crossover, safety and pharmacokinetic (PK) study to evaluate 3 once-daily doses of umeclidinium (GSK573719; UMEC) in adolescent asthma subjects aged 12 through 17 years,) who are currently using asthma medications that do not contain inhaled corticosteroids (non-ICS). The objectives are to investigate safety and tolerability, and PK after a 7-day (+2) repeat once-daily dose of UMEC (15.6, 62.5, and 250 mcg) in asthmatic adolescent subjects. Safety endpoints will include reported adverse events, vital signs, ECGs, clinical laboratory tests, and rescue albuterol use. The PK endpoints will include serial PK (plasma and urine) concentrations and derived parameters.
Twenty four subjects will be randomized to participate in the study for up to 7 weeks (including: an initial screening visit, a 7 to 14-day run-in, and 2 treatment periods each of 7 (+2) day duration, with a washout period of 7-14 days between treatment periods). There will be a Follow-up Visit approximately one week after the end of the second treatment period. Subjects will refrain from using rescue medication for 4 hours prior to any clinic visits, unless for emergency.
During each treatment period, study medication will be taken once in the morning until the morning of Day 7 (+2 days) when subjects will return to the clinic for study assessments and take the last dose of study medication. On Day 7 (+2), subjects will remain in the clinic overnight for serial assessments (ECG, and PK plasma and urine samples over the 24-hours).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Repeat Dose, 2-period Incomplete Block Crossover Safety and Pharmacokinetic Study of Umeclidinium in Adolescent Asthma Subjects|
- Subject safety as measured by serial ECGs and vital signs measured on Days 7 of each treatment period and the number (and frequency) of subjects who experience adverse events after repeat doses of GSK573719 [ Time Frame: Through the expected 7 day duration for each of 2 treatment periods. ] [ Designated as safety issue: Yes ]Assessment of safety and tolerability, including: reported adverse events, clinical laboratory measurements, vital signs (heart rate and blood pressure), and electrocardiographic (ECG) parameters.
- Subject safety as measured by ECGs and vital signs measures on Day 1 of each treatment period [ Time Frame: Through the expected 6 hour duration of in clinic stay ] [ Designated as safety issue: No ]Assessment of safety and tolerability, including: vital signs (heart rate and blood pressure), and electrocardiographic (ECG) parameters.
- Pharmacokinetic parameters such as Cmax, AUC, half-life, Tmax of GSK573719 after repeat dosing. [ Time Frame: predose, 5, 15 and 30 minutes and, 1, 2, 4, 6, 8, 12, and 24, hours on Day 7 of dosing ] [ Designated as safety issue: No ]To characterise the PK profile of repeat doses of GSK573719 in adolescent asthmatic subjects
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||March 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Investigational treatment - Swedish Orange Coloured, opaque hard gelatin capsule
Novel Dry-Powder Inhaler
Placebo Comparator: GSK573719 matched-placebo
Novel Dry-Powder Inhaler
Other Name: umeclidinium
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653483
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|