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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

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