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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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Study will investigate the pharmacodynamics of a dual pharmacophore in which a combination of GSK961081 and Propanolol is used to give a total effect of bronchodilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | Eligible subjects will receive GSK961081 (400 micrograms or 1200 micrograms), GSK961081 matching placebo, propranolol (80 milligrams) and propranolol matching placebo in five treatment sessions through ten different crossover treatment sequences. There will be a washout period between treatment sessions of 7 to 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK961081 | Drug | GSK961081 multidose dry powder inhaler (Diskus inhaler) will be available with dosing strengths of 400 micrograms and 1200 micrograms administered once daily in the morning. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the bronchodilation of single doses of GSK961081 over 24 hours following ß blockade with the ß antagonist propranolol as measured by sGaw in healthy subjects. | Up to 32 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety of GSK961081 after single doses of it with&without ß blockade with propranolol as measured by specific indicators | Up to 71 days | |
| Adverse events, clinical laboratory safety tests, FEV1, vital signs, 12-lead ECG parameters, blood glucose and serum potassium. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|
| Results for study MAB110553 can be found on the GSK Clinical Study Register. | View source |
| 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 |
|---|---|---|---|
| MAB110553 | Dataset Specification | 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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| ID | Term |
|---|---|
| C588122 | batefenterol |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| GSK961081 matching placebo | Drug | GSK961081 matching placebo multidose dry powder inhaler (Diskus inhaler) will be available to be administered once daily in the morning. |
|
| Propranolol | Drug | Propranolol over encapsulated tablet will be available with dosing strengths of 40 milligrams administered orally with 240 milliliters of water. |
|
| Propranolol matching placebo | Drug | Propranolol matching placebo over encapsulated tablet will be available to be administered orally with 240 milliliters of water. |
|
| Up to 71 days |
| Propranolol and GSK961081blood levels to derive pharmacokinetics | Up to 32 hours |
| Assess systemic pharmacokinetics of GSK961081 and propranolol after single doses of both | Up to 32 hours |
For additional information about this study please refer to the GSK Clinical Study Register |
| MAB110553 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MAB110553 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MAB110553 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MAB110553 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MAB110553 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MAB110553 | Statistical Analysis Plan | 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 |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |