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The purpose of this study is to see if the Pharmacokinetics and the Safety Profile of GSK573719 and GSK573719/GW642444 are effected by concurrent dosing with the PGP inhibitor verapamil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK573719 | Other | GSK573719 |
|
| GSK573719/GW642444 | Other | GSK573719/GW642444 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK573719 | Drug | 13 days dosing with GSK573719, once daily dosing from day 1 to 13, concurrent dosing with verapamil from day 9 to 13. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of plasma and urine | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| General safety and tolerability endpoints: adverse events, heart rate, systolic and diastolic blood pressure, 12- lead ECG (QTc(B), QTc(F)) and clinical laboratory safety tests. 24hr Holter monitoring | From first dose on day 1 through to Follow Up visit |
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Inclusion Criteria:
Exclusion Criteria:
an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | London | NW10 7EW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23569370 | Background | Mehta R, Kelleher D, Preece A, Hughes S, Crater G. Effect of verapamil on systemic exposure and safety of umeclidinium and vilanterol: a randomized and open-label study. Int J Chron Obstruct Pulmon Dis. 2013;8:159-67. doi: 10.2147/COPD.S40859. Epub 2013 Mar 27. |
| 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 |
|---|---|---|---|
| 113950 | Clinical Study Report | 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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| GW573719/GW573719 | Drug | 13 days dosing with GSK573719/GW573719, once daily dosing from day 1 to 13, concurrent dosing with verapamil from day 9 to 13. |
|
| Results for study 113950 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113950 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113950 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113950 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113950 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113950 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113950 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C573971 | GSK573719 |
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