Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.
This is a single centre, randomised, double blind, two-way crossover study, to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dry powder GW685698X (800?g) containing magnesium stearate. Magnesium stearate is an excipient added to improve the physical stability of inhaled dry powder formulations. Male and female patients with mild/moderate asthma will be randomised to determine which order they receive a single inhaled administration of GW685698X (800?g) with and without magnesium stearate. There will be a wash-out period of at least 5 days between doses.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Randomised, Double Blind, Two-way Crossover Study, to Examine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Inhaled Administration of GW685698X (800?g) With and Without Magnesium Stearate, in Mild/Moderate Asthmatic Patients.|
- Safety and tolerability: Vital signs: for 48 hours 12-lead ECG including QT, QTc, PR and QRS intervals for 48 hours PEFR, FEV1 for 48 hours Laboratory safety tests (clinical chemistry, haematology, urinalysis) at predose Adverse events for 46 days [ Time Frame: Vital signs: for 48 hours ]
- Plasma GW685698X concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) following single inhaled doses in mild/moderate asthmatic patients for 48 hours. Weighted mean serum cortisol (0-24 h) on Day 1. [ Time Frame: following single inhaled doses in mild/moderate asthmatic patients for 48 hours. ]
|Study Start Date:||February 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444509
|GSK Investigational Site|
|Wellington, New Zealand, 6035|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|