A Dose Ascending, Study To Examine The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of GSK233705B.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: GSK233705B
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 23.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: muscarinic receptor,; bronchodilators; Chronic obstructive pulmonary disease,

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.
    

Eligibility criteria:

        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