Status:
COMPLETED
To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken Together
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Pharmacokinetics of Mirabegron
Healthy Subjects
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The study aims to evaluate if blood levels of desipramine change whilst being dosed at the same time with daily mirabegron.
Detailed Description
This is an open-label, one-sequence crossover design study to evaluate the drug-drug interaction between mirabegron and desipramine. The effect of mirabegron on the plasma concentration of desipramine...
Eligibility Criteria
Inclusion
- Body Mass Index between 18.5 and 30.0 kg/m2 inclusive
- Subject is genotyped and phenotyped as an extensive metabolizer for CYP2D6
Exclusion
- Known or suspected hypersensitivity to YM178 or any of the components of the formulation used
- Known or suspected hypersensitivity to desipramine or any of the components of the formulation used
- Pregnant or breast feeding within 6 months before screening assessment
- Any clinical history of major depressive disorder, cardiovascular disease, urinary retention, glaucoma, thyroid disease and/or seizure disorder
- Any of the liver function tests (i.e. Alanine Aminotransferase (ALT), Asparate Aminotransferase (AST) and Alkaline phosphatase) above the upper limit of normal at repeated measurements
- Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
- Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
- Abnormal pulse rate and/or blood pressure measurements at the pre-study visit as follows: pulse rate \<40 or \>90 bpm; mean systolic blood pressure \>140 mmHg; mean diastolic blood pressure \>90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse rate will be measured automatically)
- A marked baseline prolongation of QT/QTc interval after repeated measurements of \>450 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01478568
Start Date
October 1 2008
End Date
January 1 2009
Last Update
April 10 2014
Active Locations (1)
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1
SGS Aster
Paris, France, 75015