Last updated: 11/04/2018 12:08:16
A Randomized Study Evaluating Steroid Hormone Levels, Safety And Tolerability Of GW870086X In Healthy Volunteers
GSK study ID
SIG110405
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing
Timeframe: 3 days
Secondary outcomes:
Safety & tolerability measures: heart rate, blood pressure, ECG, safety laboratory tests, lung function
Timeframe: 3 days
Total urinary free cortisol excretion
Timeframe: over 24 hours on Day 1 and Day 3.
Serum osteocalcin weighted mean
Timeframe: over 24 hours on Day 3.
Fasting glucose
Timeframe: on Day 1
mRNA steroid responsive gene panel
Timeframe: 3 days
Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax).
Timeframe: 3 days
Plasma concentrations of GW870086X and derived pharmacokinetic parameters
Timeframe: 3 days
Cortsiol urine concentrations
Timeframe: 3 days
Osteocalcin serum concentrations
Timeframe: 3 days
Interventions:
Drug: GW870086X
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
GW870086
Collaborators
Not applicable
Study date(s)
September 2007 to January 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Healthy male subjects
- Liver function tests normal
- Deemed suitable healthy subject
- History to sensitivity to the study medication
Inclusion and exclusion 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
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
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-21-01
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
Additional information
Not applicable
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