Safety, Blood Levels and Effects of GW642444

NCT00469040 | Completed Phase 1

• 1 other identifier: B2C108784
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

GW642444,; healthy subjects; magnesium stearate,

Outcome Measures

Primary Outcomes (1)

• 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

  Repeated measures on Day 1, 7 and 14

Secondary Outcomes (1)

• 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

  Repeated measures on Day 1, 7 and 14

Study Arms (5)

GW642444M 25mcg

EXPERIMENTAL

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

GW642444M 50mcg

EXPERIMENTAL

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

Drug: GW642444M for 14 days

GW642444M 100mcg

EXPERIMENTAL

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

GW642444M 200mcg

EXPERIMENTAL

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

Drug: GW642444M for 14 days

GW642444M 400mcg

EXPERIMENTAL

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

Drug: GW642444M for 14 days

Interventions

GW642444M for 14 days DRUG

M salt

Also known as: GW642444 (25, 50, 100, 200 & 400 mcg) for 14 days

GW642444M 100mcg; GW642444M 200mcg; GW642444M 25mcg; GW642444M 400mcg; GW642444M 50mcg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7NS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23232038 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study B2C108784 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: February 28, 2007
• Primary Completion: April 16, 2007
• Study Completion: April 16, 2007
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)