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

September 4, 2013 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
    • Florida
      • Miami, Florida, United States, 33014-3616

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. Severe renal impairment
severe renal impairment
Drug: YM178
oral
Other Names:
  • mirabegron
Experimental: 2. Moderate renal impairment
moderate renal impairment
Drug: YM178
oral
Other Names:
  • mirabegron
Experimental: 3. Mild renal impairment
mild renal impairment
Drug: YM178
oral
Other Names:
  • mirabegron
Experimental: 4. Normal renal function
normal renal function
Drug: YM178
oral
Other Names:
  • mirabegron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of pharmacokinetics parameters
Time Frame: day 1 - day 6
day 1 - day 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Metabolite analysis
Time Frame: day 1 - day 6
day 1 - day 6
Assessment of safety and tolerability
Time Frame: day 1 - day 6
day 1 - day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Central Contact, Astellas Pharma Global Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 8, 2008

First Submitted That Met QC Criteria

September 9, 2008

First Posted (Estimate)

September 10, 2008

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 178-CL-038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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