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The objective of the study is to assess the PK, safety and tolerability of a single dose of mirabegron alone and in combination with repeat doses of rifampin, a potent CYP3A4 inducer.
A single group of patients will receive both mirabegron alone and in combination with rifampin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | mirabegron alone |
|
| 2 | Experimental | mirabegron and rifampin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mirabegron | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess pharmacokinetics of mirabegron alone and in combination with rifampin | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety and tolerability of mirabegron alone and in combination with rifampin | one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami | Florida | 33126 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23625188 | Background | Lee J, Moy S, Meijer J, Krauwinkel W, Sawamoto T, Kerbusch V, Kowalski D, Roy M, Marion A, Takusagawa S, van Gelderen M, Keirns J. Role of cytochrome p450 isoenzymes 3A and 2D6 in the in vivo metabolism of mirabegron, a beta3-adrenoceptor agonist. Clin Drug Investig. 2013 Jun;33(6):429-40. doi: 10.1007/s40261-013-0084-y. |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| rifampin |
| Drug |
oral |
|
|
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |