Effect of GSK704838 In Healthy Volunteers

NCT ID: NCT00539825

Last Updated: 2016-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-02-29

Brief Summary

GSK704838C is a potent, pan-active mAChR antagonist, which is being developed for once-daily treatment of chronic obstructive pulmonary disease (COPD).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Anticholinergic,; Plethysmography; Muscarinic Receptor Antagonist,; COPD,; FTIH,

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

GSK704838

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subject
• Aged between 18-55 years inclusive.
• Non-smokers
• Normal spirometry
• A signed and dated written informed consent is obtained from the subject.
• The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Available to complete the study.
• The subject is =50kg with a body mass index within the range 19.0 to 29.9 kg/m2 inclusive.
• Response to ipratropium bromide

Exclusion Criteria

• Any clinically relevant and important abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead or Holter).
• A history of breathing problems
• A mean QTc(B) value > 450ms, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210ms or an ECG that is not suitable for QT measurements at screening.
• A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening.
• A mean heart rate outside the range 40-90 bpm inclusive at screening.
• History of use of tobacco- or nicotine-containing products within 6 months of screening, and/or positive urine cotinine test results at screening.
• Where participation in the study would result in donation of blood in excess of 500mL within a 56 day period at screening.
• The subject is currently taking regular (or a course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort etc.

The subject has taken:

• prescription medications for 14 days prior to first dose of study drug, or
• Over-the-counter (OTC) medications/preparations (including herbal remedies, etc.) excluding simple analgesics for 48 hours prior to first dose of study drug, unless it is judged by the Investigator not to compromise the subject's safety or influence the outcome of the study.

• The subject has participated in a study with a new molecular entity or any other trial within a period of 3 months prior first dose of study drug.
• The subject has tested positive for hepatitis C antibody (third generation enzyme immunoassay), hepatitis B surface antigen or HIV antibodies (if tested according to site SOP's) at screening.
• The subject has tested positive for drugs-of-abuse at screening.
• The subject has tested positive for urine alcohol (including ethanol) at screening.

The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study.

• The subject is unable to use the DISKUS™ and/or HandiHaler inhaler devices correctly at screening.
• The subject has a suspected history of alcohol abuse within the six months previous to the screening visit.
• The subject has a known allergy or hypersensitivity to magnesium stearate, milk protein or the excipient lactose monohydrate, iodine, ipratropium bromide, tiotropium bromide, atropine and/or any of its derivatives.
• The subject has a significant clinical history of prostatic hypertrophy or narrow angle glaucoma.
• The subject has received an allogeneic bone marrow transplant.
• The subject has claustrophobia that may be aggravated by entering the whole body plethysmography cabinet.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Harrow, Middlesex, United Kingdom

Countries

United Kingdom

Study Documents

Document Type: Annotated Case Report Form

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

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

AC6108697

Identifier Type: -

Identifier Source: org_study_id