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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01579461
First received: April 16, 2012
Last updated: September 4, 2013
Last verified: September 2013
History of Changes
April 16, 2012
September 4, 2013
November 2008
April 2009   (Final data collection date for primary outcome measure)
Assess the single dose pharmacokinetics of Mirabegron in healthy subjects compared to subjects with hepatic impairment [ Time Frame: Day 1 - Day 11 ]
AUCinf and Cmax
Same as current
Complete list of historical versions of study NCT01579461 on ClinicalTrials.gov Archive Site
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) ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects
An Open Label Single Dose Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of YM178 Compared With Healthy Subjects
The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with mild and moderate hepatic impairment compared to healthy subjects.
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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Pharmacokinetics
  • Healthy Subjects
  • Mild and Moderate Hepatic Impairment
Drug: mirabegron
oral
Other Name: YM178
  • Experimental: mild hepatic impairment
    Intervention: Drug: mirabegron
  • Experimental: moderate hepatic impairment
    Intervention: Drug: mirabegron
  • Experimental: healthy volunteers (matched with mild hepatic)
    Intervention: Drug: mirabegron
  • Experimental: healthy volunteers (matched with moderate hepatic)
    Intervention: Drug: mirabegron
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, Kupčová 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2009
April 2009   (Final data collection date for primary outcome measure)

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:

  • 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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Slovakia
 
 
NCT01579461
178-CL-039
2008-000210-77 ( EudraCT Number )
No
Not Provided
Not Provided
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
Astellas Pharma Europe B.V.
Not Provided
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
Astellas Pharma Inc
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP