A Randomized Study Evaluating Steroid Hormone Levels, Safety And Tolerability Of GW870086X In Healthy Volunteers
- Registration Number
- NCT00549497
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GW870086X GW870086X -
- Primary Outcome Measures
Name Time Method 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
Name Time Method mRNA steroid responsive gene panel 3 days 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 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇦🇺Herston, Queensland, Australia