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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/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
Treatment: Drugs - GW870086X

Other: GW870086X -


Treatment: Drugs: GW870086X
Intervention code [1] 0 0
Treatment: Drugs
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
N/A
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
GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids
but is also less potent. This study will look at higher doses to confirm the improved safety
profile.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00549497
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00549497