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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00549497




Registration number
NCT00549497
Ethics application status
Date submitted
24/10/2007
Date registered
25/10/2007
Date last updated
3/02/2017

Titles & IDs
Public title
A Randomized Study Evaluating Steroid Hormone Levels, Safety And Tolerability Of GW870086X In Healthy Volunteers
Scientific title
A Randomized, Double-blind, Placebo-controlled, Dose Ascending, 3-cohort Parallel Group Study to Measure the Systemic Cortisol Profile and Evaluate the Safety, Tolerability and Pharmacokinetics of GW870086X, Administered as Single Doses (12mg and 15mg), and Repeat Doses Over 3 Days (6mg, 12mg and 15mg) in Healthy Male Subjects
Secondary ID [1] 0 0
SIG110405
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
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other: GW870086X -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing
Timepoint [1] 0 0
3 days
Secondary outcome [1] 0 0
Safety & tolerability measures: heart rate, blood pressure, ECG, safety laboratory tests, lung function
Timepoint [1] 0 0
3 days
Secondary outcome [2] 0 0
Total urinary free cortisol excretion
Timepoint [2] 0 0
over 24 hours on Day 1 and Day 3.
Secondary outcome [3] 0 0
Serum osteocalcin weighted mean
Timepoint [3] 0 0
over 24 hours on Day 3.
Secondary outcome [4] 0 0
Fasting glucose
Timepoint [4] 0 0
on Day 1
Secondary outcome [5] 0 0
mRNA steroid responsive gene panel
Timepoint [5] 0 0
3 days
Secondary outcome [6] 0 0
Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax).
Timepoint [6] 0 0
3 days
Secondary outcome [7] 0 0
Plasma concentrations of GW870086X and derived pharmacokinetic parameters
Timepoint [7] 0 0
3 days
Secondary outcome [8] 0 0
Cortsiol urine concentrations
Timepoint [8] 0 0
3 days
Secondary outcome [9] 0 0
Osteocalcin serum concentrations
Timepoint [9] 0 0
3 days

Eligibility
Key inclusion criteria
Inclusion criteria:

* Healthy male subjects
* Liver function tests normal
* 18 - 45 years old
* Non smoker
* Can provide written informed consent
* Available to complete the whole trial
* Can use the inhalation device correctly
* Able to read, understand and write English
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

* Deemed suitable healthy subject
* History to sensitivity to the study medication
* Any history of breathing problems in adult life
* Participated in another trial within 30 days or 5 half-lives of the new chemical entity
* Exposed to more than 4 new chemical entities within 12 months
* Donated >500 mL blood within 2 months of screening
* Haemoglobin level < 13g/dl
* Use of prescription or non-prescription drugs within 7 days of first dose
* Taking drugs that significantly inhibit cytochrome P450 subfamily enzyme CYP3A4
* Drinks more than 4 units a day or 28 units a week
* Cannot use DISKHALER device correctly
* Positive HepB, HepC within 3 months of screening
* Positive HIV test
* Positive pre study drug/alcohol screen
* Significant cardiac conduction abnormalities
* Risk of non-compliance

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
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
1/09/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00549497