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

NCT ID: NCT00549497

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-01-31

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GW870086X

Group Type: OTHER

GW870086X

Intervention Type: DRUG

Interventions

GW870086X

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Herston, Queensland, Australia

Countries

Australia

References

Dolle S, Hielscher N, Bareille PJ, Hardes K, Robertson J, Worm M. Clinical efficacy and tolerability of a novel selective corticosteroid in atopic dermatitis--two randomised controlled trials. Skin Pharmacol Physiol. 2015;28(3):159-66. doi: 10.1159/000367696. Epub 2015 Jan 20.

Reference Type: DERIVED

PMID: 25614148 (View on PubMed)

Other Identifiers

SIG110405

Identifier Type: -

Identifier Source: org_study_id