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
  Purpose

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


Condition Intervention Phase
Pharmacokinetics
Healthy Subjects
Mild and Moderate Hepatic Impairment
Drug: mirabegron
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Assess the single dose pharmacokinetics of Mirabegron in healthy subjects compared to subjects with hepatic impairment [ Time Frame: Day 1 - Day 11 ] [ Designated as safety issue: No ]
    AUCinf and Cmax


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mild hepatic impairment Drug: mirabegron
oral
Other Name: YM178
Experimental: moderate hepatic impairment Drug: mirabegron
oral
Other Name: YM178
Experimental: healthy volunteers (matched with mild hepatic) Drug: mirabegron
oral
Other Name: YM178
Experimental: healthy volunteers (matched with moderate hepatic) Drug: mirabegron
oral
Other Name: YM178

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579461

Locations
Slovakia
FNsP Bratislava, nemocnica akad. L. Dérera; Klinika pracovného lekárstva a toxikológie
Bratislava, Slovakia, 83305
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier: NCT01579461     History of Changes
Other Study ID Numbers: 178-CL-039, 2008-000210-77
Study First Received: April 16, 2012
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration
Slovakia: State Institute for Drug Control

Keywords provided by Astellas Pharma Inc:
Pharmacokinetics
mirabegron
hepatic impairment
Phase 1

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014