A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
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ClinicalTrials.gov Identifier: NCT00750620 |
Recruitment Status :
Completed
First Posted : September 10, 2008
Last Update Posted : September 5, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Impairment | Drug: YM178 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Effect of Mild, Moderate and Severe Renal Impairment on the Pharmacokinetics of YM178 |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | September 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1. Severe renal impairment
severe renal impairment
|
Drug: YM178
oral
Other Name: mirabegron |
Experimental: 2. Moderate renal impairment
moderate renal impairment
|
Drug: YM178
oral
Other Name: mirabegron |
Experimental: 3. Mild renal impairment
mild renal impairment
|
Drug: YM178
oral
Other Name: mirabegron |
Experimental: 4. Normal renal function
normal renal function
|
Drug: YM178
oral
Other Name: mirabegron |
- Assessment of pharmacokinetics parameters [ Time Frame: day 1 - day 6 ]
- Metabolite analysis [ Time Frame: day 1 - day 6 ]
- Assessment of safety and tolerability [ Time Frame: day 1 - day 6 ]

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Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- good health other than renal impairment
- body mass index (BMI) between 18 and 40 kg/m2
Exclusion Criteria:
- subject with renal impairment has not been on stable dose of concomitant medication for at least 2 weeks
- subject has liver enzyme abnormalities

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750620
United States, California | |
Anaheim, California, United States, 92801 | |
United States, Florida | |
Miami, Florida, United States, 33014-3616 |
Study Director: | Central Contact | Astellas Pharma Global Development |
Publications:
Responsible Party: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00750620 |
Other Study ID Numbers: |
178-CL-038 |
First Posted: | September 10, 2008 Key Record Dates |
Last Update Posted: | September 5, 2013 |
Last Verified: | September 2013 |
mild, moderate, and severe renal impaired subjects normal renal function subjects Glomerular filtration rate (GFR) |
Modification of Diet in Renal Disease (MDRD) formula YM178 pharmacokinetics |
Renal Insufficiency Kidney Diseases Urologic Diseases Mirabegron Adrenergic beta-3 Receptor Agonists Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |