Safety, Blood Levels and Effects of GW642444

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 Extra-pulmonary Pharmacodynamics of Inhaled Doses of GW642444M Formulated With Magnesium Stearate in Healthy Subjects

GW642444 (the study medicine) is a new experimental medicine for treating asthma and chronic obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. We hope that the study medicine will work by relaxing the muscles in the airways and help to keep the airways open, and make breathing easier. The study medicine might improve on available treatments by having fewer side-effects, and by working faster and for longer, so that patients could take it once daily, instead of twice daily.

When a medicine is made into a form ready to be given to patients, inactive ingredients are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In this study, the study medicine contains the inactive ingredient magnesium stearate.

We need to check that the study medicine doesn't cause problems when inhaled along with magnesium stearate. So, we're doing this study in healthy people to find out the answers to these questions.

1)Do repeated once-daily doses of the study medicine cause any important side effects when inhaled, along with magnesium stearate, as a fine powder? 2)How much of the study medicine gets into the bloodstream and how long does the body take to get rid of it?

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

  • United Kingdom
      • London, United Kingdom, NW10 7NS
        • 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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • healthy males and females (of non-childbearing potential) aged 18-55
  • body weight >50kg with BMI 19-29.9 kg/m2
  • normal ECG recording
  • non-smoker

Exclusion criteria:

  • high blood pressure (above 140/90 mmHg)
  • pulse outside range 45 - 90 bpm
  • history of breathing problems e.g. asthma
  • low haemoglobin (<11 g/dL)
  • blood donation within 56 days of study start
  • taking regular medication
  • participation in another trial within 4 months of study start
  • history of drug or alcohol abuse
  • abnormal clinical laboratory tests
  • known allergies

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
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GW642444M 25mcg
In Cohort 1 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 25 mcg.
Drug: GW642444M for 14 days
M salt
Other Names:
  • GW642444 (25
  • 50
  • 100
  • 200 & 400 mcg) for 14 days
Experimental: GW642444M 50mcg
Subjects after randomization will receive two inhalations of 25 mcg GW642444M in Cohort 1.
Drug: GW642444M for 14 days
M salt
Other Names:
  • GW642444 (25
  • 50
  • 100
  • 200 & 400 mcg) for 14 days
Experimental: GW642444M 100mcg
In Cohort 2 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 100 mcg.
Drug: GW642444M for 14 days
M salt
Other Names:
  • GW642444 (25
  • 50
  • 100
  • 200 & 400 mcg) for 14 days
Experimental: GW642444M 200mcg
Subjects after randomization will receive two inhalations of 100 mcg GW642444M in Cohort 2.
Drug: GW642444M for 14 days
M salt
Other Names:
  • GW642444 (25
  • 50
  • 100
  • 200 & 400 mcg) for 14 days
Experimental: GW642444M 400mcg
Subjects after randomization will receive two inhalations of 200 mcg GW642444M in Cohort 3.
Drug: GW642444M for 14 days
M salt
Other Names:
  • GW642444 (25
  • 50
  • 100
  • 200 & 400 mcg) for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
General safety and tolerability as measured by ECG, blood pressure, pulse rate and blood and urine tests. Repeated measures on Day 1, 7 and 14
Time Frame: Repeated measures on Day 1, 7 and 14
Repeated measures on Day 1, 7 and 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Effects of the medicine on the body as measured by potassium and glucose levels in the blood. Monitoring of the study medicine in the body by analysis of blood samples. Repeated measures on Day 1, 7 and 14
Time Frame: Repeated measures on Day 1, 7 and 14
Repeated measures on Day 1, 7 and 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

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 28, 2007

Primary Completion (Actual)

April 16, 2007

Study Completion (Actual)

April 16, 2007

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 4, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2C108784

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: B2C108784
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: B2C108784
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: B2C108784
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: B2C108784
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: B2C108784
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: B2C108784
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: B2C108784
    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.

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