A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00750620
First received: September 8, 2008
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Renal Impairment
Drug: YM178
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Assessment of pharmacokinetics parameters [ Time Frame: day 1 - day 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolite analysis [ Time Frame: day 1 - day 6 ] [ Designated as safety issue: No ]
  • Assessment of safety and tolerability [ Time Frame: day 1 - day 6 ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00750620     History of Changes
Other Study ID Numbers: 178-CL-038
Study First Received: September 8, 2008
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014