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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

NCT ID: NCT01579461

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pharmacokinetics Healthy Subjects Mild and Moderate Hepatic Impairment

Keywords

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Pharmacokinetics mirabegron hepatic impairment Phase 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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mild hepatic impairment

Group Type EXPERIMENTAL

mirabegron

Intervention Type DRUG

oral

moderate hepatic impairment

Group Type EXPERIMENTAL

mirabegron

Intervention Type DRUG

oral

healthy volunteers (matched with mild hepatic)

Group Type EXPERIMENTAL

mirabegron

Intervention Type DRUG

oral

healthy volunteers (matched with moderate hepatic)

Group Type EXPERIMENTAL

mirabegron

Intervention Type DRUG

oral

Interventions

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mirabegron

oral

Intervention Type DRUG

Other Intervention Names

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YM178

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Europe B.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Study Manager

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

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FNsP Bratislava, nemocnica akad. L. Dérera; Klinika pracovného lekárstva a toxikológie

Bratislava, , Slovakia

Site Status

Countries

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Slovakia

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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2008-000210-77

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

178-CL-039

Identifier Type: -

Identifier Source: org_study_id