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Study to compare the metabolic and electrolyte effects of a single oral dose of 320 mg ritobegron administered alone or with a pre- and comedication with bisoprolol, propranolol and acipimox. In addition, to compare the metabolic and electrolyte effects of a single dose of 320 mg ritobegron with those of a single inhalatory dose of 100 μg salmeterol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
| |
| Treatment B | Experimental |
| |
| Treatment C | Experimental |
| |
| Treatment D | Experimental |
| |
| Treatment E | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KUC 7483 CL | Drug |
| ||
| Bisoprolol |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in glucose | up to 24 hours after administration of study drug | |
| Percentage change from baseline in glucose | up to 24 hours after administration of study drug | |
| Absolute change from baseline in free fatty acids (FFA) | up to 24 hours after administration of study drug | |
| Percentage change from baseline in FFA | up to 24 hours after administration of study drug | |
| Absolute change from baseline in insulin | up to 24 hours after administration of study drug | |
| Percentage change from baseline in insulin | up to 24 hours after administration of study drug | |
| Absolute change from baseline in C-Peptide | up to 24 hours after administration of study drug | |
| Percentage change from baseline in C-Peptide | up to 24 hours after administration of study drug | |
| Absolute change from baseline in Potassium | up to 24 hours after administration of study drug | |
| Percentage change from baseline in Potassium | up to 24 hours after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 80 days | |
| Number of subjects with clinically relevant changes in laboratory tests | up to 24 hours after administration of study drug | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| D011433 | Propranolol |
| C027696 | acipimox |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Drug |
|
| Propranolol | Drug |
|
| Acipimox | Drug |
|
| Salmeterol | Drug |
|
| Absolute change from baseline in Magnesium | up to 24 hours after administration of study drug |
| Percentage change from baseline in Magnesium | up to 24 hours after administration of study drug |
| Absolute change from baseline in cAMP | up to 24 hours after administration of study drug |
| Percentage change from baseline in cAMP | up to 24 hours after administration of study drug |
| Number of subjects with clinically relevant changes in vital signs |
| up to 24 hours after administration of study drug |
| Number of subjects with clinically relevant findings in electrocardiogram | up to 24 hours after administration of study drug |
| Number of subjects with clinically relevant changes in physical examination | Baseline, within 10 days after last drug administration |
| Maximum measured concentration of the analyte in plasma | up to 24 hours after administration of study drug |
| Time from dosing to the maximum concentration of the analyte in plasma | up to 24 hours after administration of study drug |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 4 hours | up to 24 hours after administration of study drug |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |