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

NCT01579461 | Completed Phase 1

• 2 other identifiers: 178-CL-0392008-000210-77
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics; Healthy Subjects; Mild and Moderate Hepatic Impairment

Keywords

Pharmacokinetics; mirabegron; hepatic impairment; Phase 1

Outcome Measures

Primary Outcomes (1)

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

  AUCinf and Cmax

  Day 1 - Day 11

Secondary Outcomes (1)

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

  Day 1 - End of Study (Up to Day 19)

Study Arms (4)

mild hepatic impairment

EXPERIMENTAL

Drug: mirabegron

moderate hepatic impairment

EXPERIMENTAL

Drug: mirabegron

healthy volunteers (matched with mild hepatic)

EXPERIMENTAL

Drug: mirabegron

healthy volunteers (matched with moderate hepatic)

EXPERIMENTAL

Drug: mirabegron

Interventions

mirabegron DRUG

oral

Also known as: YM178

healthy volunteers (matched with mild hepatic); healthy volunteers (matched with moderate hepatic); mild hepatic impairment; moderate hepatic impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (1)

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

Bratislava, 83305, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 23208320 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 18, 2012
• Study Start: November 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

SL (1)