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The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Severe renal impairment | Experimental | severe renal impairment |
|
| 2. Moderate renal impairment | Experimental | moderate renal impairment |
|
| 3. Mild renal impairment | Experimental | mild renal impairment |
|
| 4. Normal renal function | Experimental | normal renal function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM178 | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacokinetics parameters | day 1 - day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite analysis | day 1 - day 6 | |
| Assessment of safety and tolerability | day 1 - day 6 |
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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 |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23208320 | Background | Dickinson J, Lewand M, Sawamoto T, Krauwinkel W, Schaddelee M, Keirns J, Kerbusch V, Moy S, Meijer J, Kowalski D, Morton R, Lasseter K, Riff D, Kupcova V, van Gelderen M. Effect of renal or hepatic impairment on the pharmacokinetics of mirabegron. Clin Drug Investig. 2013 Jan;33(1):11-23. doi: 10.1007/s40261-012-0031-3. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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|
| Miami |
| Florida |
| 33014-3616 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |