Status:
COMPLETED
A Dose Ascending, Study To Examine The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of GSK233705B.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
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, pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00453479
Start Date
March 28 2007
End Date
October 11 2007
Last Update
March 12 2018
Active Locations (4)
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1
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
2
GSK Investigational Site
Harderwijk, Netherlands, 3844 DG
3
GSK Investigational Site
Utrecht, Netherlands, 3584 CJ
4
GSK Investigational Site
Zuidlaren, Netherlands, 9471 GP