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

February 2, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4006
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: GW870086X
Drug: GW870086X

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

October 24, 2007

First Posted (Estimate)

October 25, 2007

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIG110405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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