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Aura Adolescent PK Study GSK2829332

NCT01653483 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-11-12

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

GSK573719

Novel Dry-Powder Inhaler

DRUG

GSK573719matched-placebo

Novel Dry-Powder Inhaler

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-09-30
Completion
2013-03-31

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Diseases
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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 NCT01653483 on ClinicalTrials.gov