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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
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: YM178 Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Assessment of pharmacokinetics parameters [ Time Frame: day 1 - day 6 ]

Secondary Outcome Measures :
  1. Metabolite analysis [ Time Frame: day 1 - day 6 ]
  2. Assessment of safety and tolerability [ Time Frame: day 1 - day 6 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, California
Anaheim, California, United States, 92801
United States, Florida
Miami, Florida, United States, 33014-3616
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Central Contact Astellas Pharma Global Development
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Link to Results on JAPIC  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00750620     History of Changes
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

Keywords provided by Astellas Pharma Inc:
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

Additional relevant MeSH terms:
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