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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00549497

Enrollment

Registered

2007-10-25

Start date

2007-09-30

Completion date

2008-01-31

Last updated

2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

GW870086X, inhaled, asthma, cortisol, pharmacokinetics, osteocalcin

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.

Interventions

DRUGGW870086X

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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
Safety & tolerability measures: heart rate, blood pressure, ECG, safety laboratory tests, lung function	3 days
Plasma concentrations of GW870086X and derived pharmacokinetic parameters	3 days
Cortsiol urine concentrations	3 days
Osteocalcin serum concentrations	3 days
Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax).	3 days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026