A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK573719 In Healthy Volunteers - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00475436

Purpose

GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK573719 when administered via inhalation in animal models supports the potential for use as a once-daily bronchodilator for COPD

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: GSK573719	Phase I

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead ECG, Holter and Lead II ECG monitoring, lung function and clinical laboratory safety tests throughout the study [ Time Frame: throughout the study ]

Secondary Outcome Measures:

- Ambulatory blood pressure for repeat dosing - 24hr Holter monitoring for repeat dosing - Plasma and urine concentrations of GSK573719 and derived pharmacokinetic parameters [ Time Frame: throughout the study ]

Enrollment:	36
Study Start Date:	May 2007
Study Completion Date:	September 2007

Detailed Description:

A single-centre, randomised, double-blind, placebo-controlled, dose-ascending, 3-cohort parallel-group study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GSK573719 administered as single doses (750µg and 1000µg) and repeat doses over 14 days (250µg-1000µg once-daily) of GSK573719 in healthy male and female subjects

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Healthy Caucasian male subjects or healthy Caucasian female subjects of non-childbearing potential
Aged between 18-55 years
Non-smokers
Normal spirometry (FEV1 = 80% of predicted, FEV1/FVC = 70%)
A signed and dated written informed consent is obtained from the subject
The subject is capable of giving informed consent
Available to complete the study
Subject has a BMI within the range 18.0-30.0kg/m2 inclusive

Exclusion criteria:

Any clinically important abnormality identified at the screening medical assessment
A history of breathing problems
A mean QTc(B) value at screening >450msec, the QTc(B) of all 3 screening ECGs are not within 10% of the mean, or an ECG that is not suitable for QT measurements
A history of elevated resting blood pressure or a mean blood pressure equal to or higher than 140/90 mmHg at screening
A mean heart rate outside the range 40-90 bpm at screening
History of use of tobacco products within 6 months of screening, or positive urine cotinine at screening
Subjects with a 2D6 poor metabolizer genotype (Caucasian)
The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study
The subject is currently taking regular (or course of) medication, whether prescribed or not
The subject has taken prescription medications within the past 2 weeks prior to dosing or OTC medications within 48 hours prior to dosing
The subject has participated in a study with a new molecular entity or any other trial within a period of 3 months prior to dosing
The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
The subject has a positive pre-study drug screen
The subject has a positive pre-study alcohol screen
The subject has a suspected history of alcohol abuse within the six months previous to the screening visit
The subject is unable to use the DISKUS
The subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives
The subject has a known allergy or hypersensitivity to milk protein or the excipient lactose monohydrate
Subjects who might have prostatic hypertrophy, bladder outlet obstruction, or narrow angle glaucoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475436

Locations

Germany
GSK Investigational Site
Berlin, Germany, 14050

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	AC4106889
Study First Received:	May 16, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00475436 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

GSK573719,
chronic obstructive pulmonary disease,
muscarinic receptor antagonist

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Healthy
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009