Repeat Dose GW685698X With Magnesium Stearate, Excipient Bridging Study, In Healthy Volunteers

August 2, 2017 updated by: GlaxoSmithKline

A Randomised, Double Blind, Placebo Controlled, Parallel Group, 14 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled GW685698X Containing Magnesium Stearate in Healthy Subjects

GW685698X is a novel glucocorticoid receptor agonist that is being developed as an orally inhaled treatment for asthma. In previous studies inhaled GW685698X was administered as a dry powder containing either lactose alone or lactose and cellobiose octaacetate. However, future dry powder GW685698X formulations will contain lactose and magnesium stearate. This study will be the first administration of this new GW685698X dry powder formulation in man and will provide safety and tolerability data to support the further development of this formulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Volunteers,
  • Aged 18-65
  • Male and females (females of non-child bearing potential or who meet the contraception criteria).
  • BMI - 19-31 kg/m2

Exclusion Criteria:

  • History of breathing problems

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: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
In Cohort A, subjects will be randomized (3:1) to receive once daily doses of GW685698X 400 microgram (mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.
Drug: GW685698X
Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS
Drug: Placebo
Subject will receive Placebo matching GW685698X via DISKUS.
Experimental: Cohort B
In Cohort B, subjects will be randomized (3:1) to receive once daily doses of GW685698X (600 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.
Drug: GW685698X
Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS
Drug: Placebo
Subject will receive Placebo matching GW685698X via DISKUS.
Experimental: Cohort C
InIn Cohort C, subjects will be randomized (3:1) to receive once daily doses of GW685698X (800 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days.
Drug: GW685698X
Subject will receive GW685698X containing magnesium stearate with unit dose strength of 400, 600 and 800 mcg inhaled via DISKUS
Drug: Placebo
Subject will receive Placebo matching GW685698X via DISKUS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability: Vital signs: systolic and diastolic blood pressure (BP), heart rate (HR) 12-lead ECG including QT, QTc, PR and QRS intervals PEFR Laboratory safety tests (clinical chemistry, haematology, urinalysis) Adverse events
Time Frame: Up to Day 16
Up to Day 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentrations and pharmacokinetic parameters (AUC, Cmax, t1/2, tmax) for GW685698X on Day 1 and Day 14. Weighted mean serum cortisol, (0-24 h) on Day 14.
Time Frame: Weighted mean serum cortisol, (0-24 h) on Day 14
Weighted mean serum cortisol, (0-24 h) on Day 14

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

  • This study has not been published in the scientific literature.

Helpful Links

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)

February 15, 2007

Primary Completion (Actual)

April 25, 2007

Study Completion (Actual)

April 25, 2007

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

August 28, 2007

First Posted (Estimate)

August 30, 2007

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HZA102928

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: HZA102928
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: HZA102928
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: HZA102928
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: HZA102928
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: HZA102928
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: HZA102928
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Clinical Study Report
    Information identifier: HZA102928
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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.

Clinical Trials on Asthma

Clinical Trials on GW685698X

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe