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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522678
• Other study ID #: HZA102928
• Status: Completed
• Phase: Phase 1
• First received: March 7, 2007
• Last updated: August 2, 2017
• Start date: February 15, 2007
• Est. completion date: April 25, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 25, 2007
• Est. primary completion date: April 25, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study HZA102928 can be found on the GSK Clinical Study Register.