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CompletedNCT01579461Updated Sep 5, 2013

A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects

A Phase 1 interventional study of mirabegron in Pharmacokinetics, Healthy Subjects and Mild and Moderate Hepatic Impairment, sponsored by Astellas Pharma Europe B.V.. Completed at 1 site in Slovakia. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-05.

Sponsored by Astellas Pharma Europe B.V. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with mild and moderate hepatic impairment compared to healthy subjects.

Read the detailed description

Healthy subjects and subjects with mild and moderate hepatic impairment are admitted on Day 1. Subjects receive a single oral dose of Mirabegron in the morning of Day 1 and will remain in the unit till Day 5 with outpatient visits on Days 6 and 7 for healthy subjects and Days 6, 7, 9 and 11 for subjects with hepatic impairment. Blood sampling for PK assessment will be up to 144 hrs post dose for healthy subjects and up to 240 hrs post dose for subjects with hepatic impairment. An additional blood sample was obtained for all subjects 4 hrs post dose for protein binding.

02

Conditions studied

  • Pharmacokinetics
  • Healthy Subjects
  • Mild and Moderate Hepatic Impairment

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Keywords

  • Pharmacokinetics
  • mirabegron
  • hepatic impairment
  • Phase 1
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Astellas Pharma Europe B.V. is the lead sponsor of 93 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body Mass Index more than or equal to 18.0 and less than 32.0 kg/m2 (men and women)
  • Subject is genotyped as an extensive metabolizer for CYP2D6
  • For subjects with mild/moderate hepatic impairment: Hepatic dysfunction scored as mild impairment ((between 5-6 in the Child-Pugh's classification) and moderate impairment (between 7-9 in the Child-Pugh's classification)
  • Healthy subject with normal hepatic function

Exclusion criteria

Exclusion Criteria:

  • Known or suspected hypersensitivity to mirabegron or any components of the formulations used
  • A marked prolongation at screening of QT/QTC interval demonstrated by a mean QTcF interval >450 ms for male subjects and a mean QTcF interval >470 ms for female subjects (based on 3 ECGs)
  • Abnormal pulse rate and/or blood pressure measurements at the pre-study visit taken in triplicate by means of an automatic device, after subject has been resting in supine position for 5 min: •Pulse rate \<40 or >90 bpm; Mean systolic blood pressure \<90 or >160 mmHg; Mean diastolic blood pressure \<40 or >95 mmHg
  • Healthy subjects: use of any prescribed or OTC drugs (except paracetamol, with a maximum of 3g/day) in the 2 weeks prior to admission to the clinical unit
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    mild hepatic impairment

    Drug: mirabegron

  • Experimental
    moderate hepatic impairment

    Drug: mirabegron

  • Experimental
    healthy volunteers (matched with mild hepatic)

    Drug: mirabegron

  • Experimental
    healthy volunteers (matched with moderate hepatic)

    Drug: mirabegron

Interventions

  • Drugmirabegron

    oral

    Also known as: YM178

06

What researchers measure

Primary outcomes

  1. Assess the single dose pharmacokinetics of Mirabegron in healthy subjects compared to subjects with hepatic impairment

    AUCinf and Cmax

    Time frame: Day 1 - Day 11

Secondary outcomes

  1. Safety assessed by incidence of adverse events, lab tests, physical exam, ECG and vital signs

    Time frame: Day 1 - End of Study (Up to Day 19)

07

Study locations

1 site
  • FNsP Bratislava, nemocnica akad. L. Dérera; Klinika pracovného lekárstva a toxikológie
    Bratislava, 83305, Slovakia
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
NCT01579461
Lead sponsor
Astellas Pharma Europe B.V.
Responsible party
Sponsor
First posted
Apr 18, 2012
Start date
Nov 2008
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Sep 5, 2013

Study contacts

Clinical Study Manager
study chair · Astellas Pharma Europe B.V.

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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