Single Dose GW685698X Magnesium Stearate Study In Asthmatic Patients.

A Double-blind, Placebo-controlled, Crossover Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Dose Dry Powder GW685698X Containing Magnesium Stearate in Subjects With Mild to Moderate Asthmatic Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00444509

Enrollment

Registered

2007-03-07

Start date

2007-02-17

Completion date

2007-04-09

Last updated

2017-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthmatic Patients

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.

Interventions

DRUGGW685698X

GW685698X will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS

DRUGGW685698X containing magnesium stearate

GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026