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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00475436
First received: May 16, 2007
Last updated: October 27, 2016
Last verified: October 2016
  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
Pulmonary Disease, Chronic Obstructive
Drug: GSK573719
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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 Singledoses (750 μg and 1000 μg) and Repeat Doses Over 14 Days (250 μg-1000 μg Once-daily) of GSK573719 in Healthy Male and Female Subjects.

Resource links provided by NLM:


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
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: GSK573719

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: AC4106889
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: AC4106889
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: AC4106889
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: AC4106889
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: AC4106889
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: AC4106889
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: AC4106889
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00475436     History of Changes
Other Study ID Numbers: AC4106889
Study First Received: May 16, 2007
Last Updated: October 27, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
muscarinic receptor antagonist
GSK573719,
chronic obstructive pulmonary disease,

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on May 25, 2017