Safety, Blood Levels and Effects of GW642444

NCT ID: NCT00469040

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-04-16

Brief Summary

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?

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GW642444M 25mcg

In Cohort 1 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 25 mcg.

Group Type: EXPERIMENTAL

GW642444M for 14 days

Intervention Type: DRUG

M salt

GW642444M 50mcg

Subjects after randomization will receive two inhalations of 25 mcg GW642444M in Cohort 1.

Group Type: EXPERIMENTAL

GW642444M for 14 days

Intervention Type: DRUG

M salt

GW642444M 100mcg

In Cohort 2 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 100 mcg.

Group Type: EXPERIMENTAL

GW642444M for 14 days

Intervention Type: DRUG

M salt

GW642444M 200mcg

Subjects after randomization will receive two inhalations of 100 mcg GW642444M in Cohort 2.

Group Type: EXPERIMENTAL

GW642444M for 14 days

Intervention Type: DRUG

M salt

GW642444M 400mcg

Subjects after randomization will receive two inhalations of 200 mcg GW642444M in Cohort 3.

Group Type: EXPERIMENTAL

GW642444M for 14 days

Intervention Type: DRUG

M salt

Interventions

GW642444M for 14 days

M salt

Intervention Type: DRUG

Other Intervention Names

GW642444 (25; 50; 100; 200 & 400 mcg) for 14 days

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

London, , United Kingdom

Countries

United Kingdom

References

Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther. 2013 Apr;26(2):256-64. doi: 10.1016/j.pupt.2012.12.001. Epub 2012 Dec 8.

Reference Type: BACKGROUND

PMID: 23232038 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

B2C108784

Identifier Type: -

Identifier Source: org_study_id