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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018690-38 | EudraCT Number |
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The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination.
Treatment arm 1 (effect of mirabegron on tamsulosin): Subjects are randomized into one of two sequences.
Subjects receive 2 singles doses of tamsulosin, once in the absence of mirabegron and once in the presence of mirabegron.
24-hour Cardiovascular (CV) profiles are taken at both baseline days and after the single dose of tamsulosin /combination dose in each sequence. Regular blood samples are also taken to check for a potential Pharmacokinetic (PK) interaction.
Treatment arm 2 (effect of tamsulosin on mirabegron): Subjects are randomized into one of two sequences.
Subjects receive 2 singles doses of mirabegron, once in the absence of tamsulosin and once in the presence of tamsulosin.
24-hour CV profiles are taken at both baseline days and after the single dose of mirabegron/combination dose in each sequence. Regular blood samples are also taken to check for a potential PK interaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 | Experimental | tamsulosin singles doses; mirabegron multiple dose |
|
| Treatment Arm 2 | Experimental | mirabegron single doses; tamsulosin multiple dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mirabegron | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular interactions assessed by blood pressure and pulse rate | Pre-dose until 24 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events | Arm 1: From time of combination dose until 4 days after combination dose / Arm 2: From time of combination dose until 8 days after combination dose | |
| Potential PK interaction of the combination dosing assessed by serial plasma sampling |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance CRU Ltd | Leeds | LS2 9LH | United Kingdom |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| tamsulosin | Drug | oral |
|
|
| Arm 1: From time of combination dose until 4 days after combination dose (10 time points) / Arm 2: From time of combination dose until 8 days after combination dose (14 time points) |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |