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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00522678

Collaborator

(none)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: GW685698X Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

A Randomised, Double Blind, Placebo Controlled, Parallel Group, 14 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled GW685698X Containing Magnesium Stearate in Healthy Subjects

Actual Study Start Date :

Feb 15, 2007

Actual Primary Completion Date :

Apr 25, 2007

Actual Study Completion Date :

Apr 25, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: GW685698X Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS Drug: Placebo Subject will receive Placebo matching GW685698X via DISKUS.
Experimental: 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.	Drug: GW685698X Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS Drug: Placebo Subject will receive Placebo matching GW685698X via DISKUS.
Experimental: 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.	Drug: GW685698X Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS Drug: Placebo Subject will receive Placebo matching GW685698X via DISKUS.

Arm

Intervention/Treatment

Experimental: 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.

Drug: GW685698X

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

Drug: Placebo

Subject will receive Placebo matching GW685698X via DISKUS.

Experimental: 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.

Drug: GW685698X

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

Drug: Placebo

Subject will receive Placebo matching GW685698X via DISKUS.

Experimental: 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.

Drug: GW685698X

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

Drug: Placebo

Subject will receive Placebo matching GW685698X via DISKUS.

Outcome Measures

Primary Outcome Measures

Safety and tolerability: Vital signs: systolic and diastolic blood pressure (BP), heart rate (HR) 12-lead ECG including QT, QTc, PR and QRS intervals PEFR Laboratory safety tests (clinical chemistry, haematology, urinalysis) Adverse events [Up to Day 16]

Secondary Outcome Measures

Plasma concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) for GW685698X on Day 1 and Day 14. Weighted mean serum cortisol, (0-24 h) on Day 14. [Weighted mean serum cortisol, (0-24 h) on Day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Melbourne	Victoria	Australia	3004

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

This study has not been published in the scientific literature.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00522678

Other Study ID Numbers:

HZA102928

First Posted:

Aug 30, 2007

Last Update Posted:

Aug 4, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by GlaxoSmithKline

Healthy Volunteers

Study Results

No Results Posted as of Aug 4, 2017