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CompletedNCT00750620Updated Sep 5, 2013

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

A Phase 1 interventional study of YM178 in Renal Impairment, sponsored by Astellas Pharma Inc. Completed at 2 sites in United States. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-05.

Sponsored by Astellas Pharma Inc · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Non-randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Impairment

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Keywords

  • 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
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 33 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    1. Severe renal impairment

    severe renal impairment

    Drug: YM178

  • Experimental
    2. Moderate renal impairment

    moderate renal impairment

    Drug: YM178

  • Experimental
    3. Mild renal impairment

    mild renal impairment

    Drug: YM178

  • Experimental
    4. Normal renal function

    normal renal function

    Drug: YM178

Interventions

  • DrugYM178

    oral

    Also known as: mirabegron

06

What researchers measure

Primary outcomes

  1. Assessment of pharmacokinetics parameters

    Time frame: day 1 - day 6

Secondary outcomes

  1. Metabolite analysis

    Time frame: day 1 - day 6

  2. Assessment of safety and tolerability

    Time frame: day 1 - day 6

07

Study locations

2 sites
  • Anaheim, California 92801, United States
  • Miami, Florida 33014-3616, United States
08

References and documents

Publications

  • 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. PubMed 23208320 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00750620
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Sep 10, 2008
Start date
Sep 2008
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Sep 5, 2013

Study contacts

Central Contact
study director · Astellas Pharma Global Development

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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