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

NCT00475436 | Completed Phase 1

• 1 other identifier: AC4106889
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

muscarinic receptor antagonist; GSK573719,; chronic obstructive pulmonary disease,

Outcome Measures

Primary Outcomes (1)

• 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

  throughout the study

Secondary Outcomes (1)

• - Ambulatory blood pressure for repeat dosing - 24hr Holter monitoring for repeat dosing - Plasma and urine concentrations of GSK573719 and derived pharmacokinetic parameters

  throughout the study

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: GSK573719

Interventions

GSK573719 DRUG

Arm 1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Berlin, 14050, Germany

Location

Related Publications (1)

• 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.

  PMID: 23784369 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 AC4106889 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK573719

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 16, 2007
• First Posted: May 21, 2007
• Study Start: May 14, 2007
• Primary Completion: September 18, 2007
• Study Completion: September 18, 2007
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)