Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00444509

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: GW685698X	Phase I

MedlinePlus related topics: Asthma

Drug Information available for: n-Octadecanoic acid GW 685698X GW 685698 Calcium stearate Aluminum monostearate Magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Safety Study
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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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. ]

Enrollment:	20
Study Start Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Clinically stable persistent mild/moderate asthma within the 4 weeks preceding the screening visit,
screening pre-bronchodilator FEV1 >or=60 % predicted,demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of
- or= 12.0% over the max of the three screening measures and an absolute change of
- or= 200 mL within 30 minutes following a single 400 mcg salbutamol dose, male or female (of non child bearing potential or meet the contraception criteria),
BMI 19-31 kg/m2,
Non-smoker,
refrains from use of prohibited medication within the specified timeframes

Exclusion criteria:

Pregnant or nursing females
History of life threatening asthma
Subjects who are unable to stop taking protocol defined prohibited medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444509

Locations

New Zealand
GSK Investigational Site
Wellington 6004, New Zealand, 6004

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	HZA108799
Study First Received:	March 6, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00444509 History of Changes
Health Authority:	New Zealand: Health and Disability Ethics Committees

Keywords provided by GlaxoSmithKline:

Asthmatic Patients

Study placed in the following topic categories:

Asthma

ClinicalTrials.gov processed this record on May 06, 2009