A Randomized Study Evaluating Steroid Hormone Levels, Safety And Tolerability Of GW870086X In Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: GW870086X


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GW870086X<br> | Drug: GW870086X<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety & tolerability measures: heart rate, blood pressure, ECG, safety laboratory tests, lung function |  | 3 days | 
| Total urinary free cortisol excretion |  | over 24 hours on Day 1 and Day 3. | 
| Serum osteocalcin weighted mean |  | over 24 hours on Day 3. | 
| Fasting glucose |  | on Day 1 | 
| mRNA steroid responsive gene panel |  | 3 days | 
| Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax). |  | 3 days | 
| Plasma concentrations of GW870086X and derived pharmacokinetic parameters |  | 3 days | 
| Cortsiol urine concentrations |  | 3 days | 
| Osteocalcin serum concentrations |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GW870086X, inhaled, asthma, cortisol, pharmacokinetics, osteocalcin