Overview
A Randomized Study Evaluating Steroid Hormone Levels, Safety And Tolerability Of GW870086X In Healthy Volunteers
Status:
Completed
Completed
Trial end date:
2008-01-01
2008-01-01
Target enrollment:
0
0
Participant gender:
Male
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 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
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