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:
Astellas Pharma Europe BV
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe BV )
ClinicalTrials.gov Identifier:
NCT01579461
First received: April 16, 2012
Last updated: April 17, 2012
Last verified: April 2012
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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
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 BV
Investigators
| Study Chair: | Clinical Study Manager | Astellas Pharma Europe BV |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc ( Astellas Pharma Europe BV ) |
| 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: | April 17, 2012 |
| 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 June 18, 2013