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

NCT ID: NCT00475436

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-14
• Study Completion Date: 2007-09-18

Brief Summary

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

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

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

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

Study Groups

Arm 1

Group Type: EXPERIMENTAL

GSK573719

Intervention Type: DRUG

Interventions

GSK573719

Intervention Type: DRUG

Eligibility 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

• 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

Berlin, , Germany

Countries

Germany

References

Cahn A, Tal-Singer R, Pouliquen IJ, Mehta R, Preece A, Hardes K, Crater G, Deans A. Safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat inhaled doses of umeclidinium in healthy subjects: two randomized studies. Clin Drug Investig. 2013 Jul;33(7):477-88. doi: 10.1007/s40261-013-0088-7.

Reference Type: BACKGROUND

PMID: 23784369 (View on PubMed)

Study Documents

Document Type: Dataset Specification

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

Document Type: Study Protocol

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: Clinical Study Report

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

View Document

Document Type: Statistical Analysis Plan

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

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

AC4106889

Identifier Type: -

Identifier Source: org_study_id