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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00453479
First received: March 27, 2007
Last updated: July 22, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: GSK233705B
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 24
Study Start Date: March 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GSK233705B
    Other Name: GSK233705B
  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453479

Locations
Netherlands
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00453479     History of Changes
Other Study ID Numbers: AC2108378
Study First Received: March 27, 2007
Last Updated: July 22, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on April 17, 2014