A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects
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ClinicalTrials.gov Identifier: NCT01579461 |
Recruitment Status
:
Completed
First Posted
: April 18, 2012
Last Update Posted
: September 5, 2013
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Sponsor:
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
Tracking Information | ||||
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First Submitted Date ICMJE | April 16, 2012 | |||
First Posted Date ICMJE | April 18, 2012 | |||
Last Update Posted Date | September 5, 2013 | |||
Study Start Date ICMJE | November 2008 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Assess the single dose pharmacokinetics of Mirabegron in healthy subjects compared to subjects with hepatic impairment [ Time Frame: Day 1 - Day 11 ] AUCinf and Cmax
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01579461 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Safety assessed by incidence of adverse events, lab tests, physical exam, ECG and vital signs [ Time Frame: Day 1 - End of Study (Up to Day 19) ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects | |||
Official Title ICMJE | An Open Label Single Dose Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of YM178 Compared With Healthy Subjects | |||
Brief Summary | The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with mild and moderate hepatic impairment compared to healthy subjects. | |||
Detailed Description | Healthy subjects and subjects with mild and moderate hepatic impairment are admitted on Day 1. Subjects receive a single oral dose of Mirabegron in the morning of Day 1 and will remain in the unit till Day 5 with outpatient visits on Days 6 and 7 for healthy subjects and Days 6, 7, 9 and 11 for subjects with hepatic impairment. Blood sampling for PK assessment will be up to 144 hrs post dose for healthy subjects and up to 240 hrs post dose for subjects with hepatic impairment. An additional blood sample was obtained for all subjects 4 hrs post dose for protein binding. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE |
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Intervention ICMJE | Drug: mirabegron
oral
Other Name: YM178 |
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Study Arms |
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Publications * | 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, Kupčová 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
32 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | April 2009 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Slovakia | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01579461 | |||
Other Study ID Numbers ICMJE | 178-CL-039 2008-000210-77 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Astellas Pharma Inc ( Astellas Pharma Europe B.V. ) | |||
Study Sponsor ICMJE | Astellas Pharma Europe B.V. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Astellas Pharma Inc | |||
Verification Date | September 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |