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

NCT ID: NCT00453479

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-28
• Study Completion Date: 2007-10-11

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC

Interventions

GSK233705B

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Eindhoven, , Netherlands

GSK Investigational Site

Harderwijk, , Netherlands

GSK Investigational Site

Utrecht, , Netherlands

GSK Investigational Site

Zuidlaren, , Netherlands

Countries

Netherlands

References

This study has not been published in the scientific literature.

Reference Type: BACKGROUND

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

AC2108378

Identifier Type: -

Identifier Source: org_study_id