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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00549497
First received: October 24, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: GW870086X
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Effect of GW870086X on cortisol levels (naturally produced steroid hormone) in the body during a single dose and after 3 days of dosing

Secondary Outcome Measures:
  • Safety & tolerability measures: heart rate, blood pressure, ECG, safety laboratory tests, lung function [ Time Frame: 3 days ]
  • Total urinary free cortisol excretion [ Time Frame: over 24 hours on Day 1 and Day 3. ]
  • Serum osteocalcin weighted mean [ Time Frame: over 24 hours on Day 3. ]
  • Fasting glucose [ Time Frame: on Day 1 ]
  • mRNA steroid responsive gene panel
  • Plasma concentrations of GW870086X and GW870086X pharmacokinetic parameters (including AUC, Cmax, t1/2 and tmax). [ Time Frame: 3 days ]
  • Plasma concentrations of GW870086X and derived pharmacokinetic parameters [ Time Frame: 3 days ]
  • Cortsiol urine concentrations [ Time Frame: 3 days ]
  • Osteocalcin serum concentrations [ Time Frame: 3 days ]

Enrollment: 36
Study Start Date: September 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW870086X
    Other Name: GW870086X
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549497

Locations
Australia, Queensland
GSK Investigational Site
Herston, Queensland, Australia, 4006
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00549497     History of Changes
Other Study ID Numbers: SIG110405
Study First Received: October 24, 2007
Last Updated: May 31, 2012
Health Authority: Australia: The Queensland Institute of Medical Research

Keywords provided by GlaxoSmithKline:
GW870086X, inhaled, asthma, cortisol, pharmacokinetics, osteocalcin

ClinicalTrials.gov processed this record on November 20, 2014