Last updated: 11/04/2018 08:17:15

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

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GSK study ID
HZA102928
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Clinicaltrials.gov ID
NCT00522678
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

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

Timeframe: Up to Day 16

Secondary outcomes:

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.

Timeframe: Weighted mean serum cortisol, (0-24 h) on Day 14

Interventions:
Drug: GW685698X
Drug: Placebo
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
This study has not been published in the scientific literature.
Medical condition
Asthma
Product
fluticasone furoate, milveterol
Collaborators
Not applicable
Study date(s)
February 2007 to April 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
  • Healthy Volunteers,
  • Aged 18-65
  • History of breathing problems
Inclusion and exclusion criteria
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

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-25-04

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study HZA102928 can be found on the GSK Clinical Study Register.
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