Repeat Dose GW685698X With Magnesium Stearate, Excipient Bridging Study, In Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-15

Study Completion Date

2007-04-25

Brief Summary

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GW685698X is a novel glucocorticoid receptor agonist that is being developed as an orally inhaled treatment for asthma. In previous studies inhaled GW685698X was administered as a dry powder containing either lactose alone or lactose and cellobiose octaacetate. However, future dry powder GW685698X formulations will contain lactose and magnesium stearate. This study will be the first administration of this new GW685698X dry powder formulation in man and will provide safety and tolerability data to support the further development of this formulation.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Cohort A

In Cohort A, subjects will be randomized (3:1) to receive once daily doses of GW685698X 400 microgram (mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.

Group Type EXPERIMENTAL

GW685698X

Intervention Type DRUG

Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS

Placebo

Intervention Type DRUG

Subject will receive Placebo matching GW685698X via DISKUS.

Cohort B

In Cohort B, subjects will be randomized (3:1) to receive once daily doses of GW685698X (600 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.

Group Type EXPERIMENTAL

GW685698X

Intervention Type DRUG

Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS

Placebo

Intervention Type DRUG

Subject will receive Placebo matching GW685698X via DISKUS.

Cohort C

InIn Cohort C, subjects will be randomized (3:1) to receive once daily doses of GW685698X (800 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.

Group Type EXPERIMENTAL

GW685698X

Intervention Type DRUG

Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS

Placebo

Intervention Type DRUG

Subject will receive Placebo matching GW685698X via DISKUS.

Interventions

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GW685698X

Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS

Intervention Type DRUG

Placebo

Subject will receive Placebo matching GW685698X via DISKUS.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Volunteers,
* Aged 18-65
* Male and females (females of non-child bearing potential or who meet the contraception criteria).
* BMI - 19-31 kg/m2

Exclusion Criteria

* History of breathing problems

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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This study has not been published in the scientific literature.

Reference Type BACKGROUND

Study Documents

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