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A Dose Ascending, Study To Examine The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of GSK233705B.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00453479
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : August 10, 2009
Information provided by:

Study Description
Brief Summary:
GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for the treatment of chronic obstructive pulmonary disease. This is a randomised, double-blind, placebo-controlled, dose ascending, parallel group study to examine the safety, tolerability, pharmacokinetics and pharmacodynamics of twice daily inhaled doses of GSK233705B for 7 days, in COPD subjects.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: GSK233705B Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: A Randomised, Double-blind, Placebo-controlled, Dose Ascending,2-cohort, Parallel Group Study to Examine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Twice-daily Inhaled Doses of GSK233705B Formulated With the Excipient Magnesium Stearate in COPD Subjects for 7-days.
Study Start Date : March 2007
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability endpoints: adverse events, vital signs, 12-lead ECG, Holter and ECG monitoring, lung function, rescue medication and clinical lab tests. These will be taken pre-dose and at multiple time points to 24 hours on day 1 and 7 of dosing

Secondary Outcome Measures :
  1. Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters. Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) measurements over 12 hours post morning dose on Days 1 and 7.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men or women who are between 40 and 75 years of age
  • Female subjects must be of non-childbearing
  • Subject diagnosed with COPD
  • Body Mass Index 18.0 - 32.0 kg/m2 (inclusive)
  • Subject is a smoker or an ex-smoker
  • Subject has post-bronchodilator (200µg salbutamol) FEV1 of = 40% to = 80% of predicted normal.
  • Subject has FEV1/FVC < 0.7 post-bronchodilator (200µg salbutamol).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Subject is available to complete all study measurements and procedures.
  • Subjects have a 24hour holter recording that is within normal limits and does not demonstrate any clinically important abnormality that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.

Exclusion Criteria:

  • Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, may affect the outcome of this study.
  • The subject has a positive pre-study alcohol screen.
  • The subject has a positive pre-study drug screen.
  • History of alcohol/drug abuse or dependence within 12 months of the study: Abuse
  • The subject has a positive pregnancy test.
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • Subject has tested positive for HIV
  • The subject has participated in a clinical trial and has received a drug or a new chemical entity within 60 days or 5 half-lives
  • Exposure to more than three new chemical entities (NCE) within 10 months prior to the first dosing day or one NCE within 3 months prior to the first dosing day.
  • The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
  • The subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives or milk protein/lactose.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
  • Subject has prostate hypertrophy or narrow angle glaucoma
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453479

GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Harderwijk, Netherlands, 3844 DG
GSK Investigational Site
Utrecht, Netherlands, 3584 CJ
GSK Investigational Site
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00453479     History of Changes
Other Study ID Numbers: AC2108378
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: August 10, 2009
Last Verified: July 2009

Keywords provided by GlaxoSmithKline:
Chronic obstructive pulmonary disease,
muscarinic receptor,

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