Clinical trial · Interventional
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
NCT01579461CI-TRIAL-00011987completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Subjects | — | UNRESOLVED | — |
| Mild and Moderate Hepatic Impairment | — | UNRESOLVED | — |
| Pharmacokinetics | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mirabegron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- mild hepatic impairment
- interventionNames
- Drug: mirabegron
- type
- EXPERIMENTAL
- label
- moderate hepatic impairment
- interventionNames
- Drug: mirabegron
- type
- EXPERIMENTAL
- label
- healthy volunteers (matched with mild hepatic)
- interventionNames
- Drug: mirabegron
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDDickinson 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