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GSK704838C is a potent, pan-active mAChR antagonist, which is being developed for once-daily treatment of chronic obstructive pulmonary disease (COPD).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK704838 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| - 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. |
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Inclusion Criteria:
Exclusion Criteria:
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 detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Harrow | Middlesex | HA1 3UJ | United Kingdom |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| AC6108697 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Serial sGaw measurements over 48 hours for the last period in each cohort dose of GSK704838 and tiotropium bromide. |
For additional information about this study please refer to the GSK Clinical Study Register |
| AC6108697 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AC6108697 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AC6108697 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AC6108697 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AC6108697 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AC6108697 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |