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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00549497
Recruitment Status : Completed
First Posted : October 25, 2007
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: GW870086X Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Arm Intervention/treatment
GW870086X Drug: GW870086X

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00549497

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00549497     History of Changes
Other Study ID Numbers: SIG110405
First Posted: October 25, 2007    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2011

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