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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Asthma

Treatments

Drug: GW870086X

Study type

Interventional

Funder types

Industry

Identifiers

NCT00549497

SIG110405

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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