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

NCT ID: NCT00750620

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Impairment

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1. Severe renal impairment

severe renal impairment

Group Type EXPERIMENTAL

YM178

Intervention Type DRUG

oral

2. Moderate renal impairment

moderate renal impairment

Group Type EXPERIMENTAL

YM178

Intervention Type DRUG

oral

3. Mild renal impairment

mild renal impairment

Group Type EXPERIMENTAL

YM178

Intervention Type DRUG

oral

4. Normal renal function

normal renal function

Group Type EXPERIMENTAL

YM178

Intervention Type DRUG

oral

Interventions

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YM178

oral

Intervention Type DRUG

Other Intervention Names

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mirabegron

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

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Anaheim, California, United States

Site Status

Miami, Florida, United States

Site Status

Countries

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United States

References

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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, Kupcova 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.

Reference Type BACKGROUND
PMID: 23208320 (View on PubMed)

Other Identifiers

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178-CL-038

Identifier Type: -

Identifier Source: org_study_id