Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: GW685698X; Drug: GW685698X containing magnesium stearate

• Registration Number: NCT00444509
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-17
• Study First Submitted: 2007-03-06
• Study First Submitted QC: 2007-03-06
• Study First Posted: 2007-03-07
• Primary Completion: 2007-04-09
• Study Completion: 2007-04-09
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-03
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment 1	GW685698X	Subjects will receive GW685698X 800 microgram (mcg) single inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses.
Treatment 2	GW685698X	Subjects will receive GW685698X 800 mcg containing magnesium stearate inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses.
Treatment 1	GW685698X containing magnesium stearate	Subjects will receive GW685698X 800 microgram (mcg) single inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses.
Treatment 2	GW685698X containing magnesium stearate	Subjects will receive GW685698X 800 mcg containing magnesium stearate inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses.

Primary Outcome Measures

Name	Time	Method
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	Vital signs: for 48 hours

Secondary Outcome Measures

Name	Time	Method
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.	following single inhaled doses in mild/moderate asthmatic patients for 48 hours.

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇿 Wellington, New Zealand