A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK573719 In Healthy Volunteers

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: GSK573719

Study type

Interventional

Funder types

Industry

Identifiers

NCT00475436

AC4106889

Details and patient eligibility

About

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

Full 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

Enrollment

36 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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