Effect of GSK704838 In Healthy Volunteers

NCT00539825 | Completed Phase 1

• 1 other identifier: AC6108697
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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,

Outcome Measures

Primary Outcomes (1)

• adverse events, vital signs,12-lead ECG, Holter and ECG monitoring,lung function and clinical lab tests. These will be taken pre-dose and at multiple time points up to 48h at each treatment period.

Secondary Outcomes (3)

• - Plasma and urine concentrations of GSK704838 and derived pharmacokinetic parameters over 48h post-dose. - Serial sGaw, Raw and FEV1 measurements over 24h post-dose.

• Serial specific airway conductance (sGaw), Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity measurements (FVC) over 24 hours post-dose of GSK704838 and tiotropium bromide.

• Serial sGaw measurements over 48 hours for the last period in each cohort dose of GSK704838 and tiotropium bromide.

Interventions

GSK704838 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 5, 2007
• Study Start: September 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: October 31, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)