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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00522678




Registration number
NCT00522678
Ethics application status
Date submitted
7/03/2007
Date registered
30/08/2007
Date last updated
4/08/2017

Titles & IDs
Public title
Repeat Dose GW685698X With Magnesium Stearate, Excipient Bridging Study, In Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
HZA102928
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GW685698X
Treatment: Drugs - Placebo

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.

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.

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.


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

Treatment: Drugs: Placebo
Subject will receive Placebo matching GW685698X via DISKUS.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to Day 16
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Weighted mean serum cortisol, (0-24 h) on Day 14

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of breathing problems

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/04/2007
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00522678
Trial related presentations / publications
This study has not been published in the scientific literature.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries