A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Mirabegron; Tamsulosin

Criteria

Inclusion Criteria:

• Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2

Exclusion Criteria:

• Known or suspected hypersensitivity to mirabegron and/or tamsulosin HCl, or any components of the formulations used

• Any of the liver function tests (i.e. Alanine Aminotransferase (ALT) and Asparate Aminotransferase (AST) above the upper limit of normal at repeated measures (at least one more time)

• Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)

• Any prior clinically significant psychiatric history including hospitalization for mental health management

• Subject is at risk of urinary retention based on medical history

• Any clinically significant abnormality following the investigator's review of the pre-study physical examination, Electrocardiogram (ECG) and clinical laboratory tests

• Heart rate and/or blood pressure measurements at the screening and admission visits as follows: Heart rate <50 or >90 bpm; mean systolic blood pressure <90 mm Hg or >140 mmHg (>160 mmHg for subjects 65 years or older); mean diastolic blood pressure <60 mm Hg or >90 mmHg (>100 mmHg for subjects 65 years or older) (blood pressure measurements to be taken after subject has been resting in supine position for 5 min; heart rate will be measured automatically; both to be taken in triplicate)

• A QTc interval of > 430 ms after repeated measurements (at least two more times), a history of syncope, orthostatic hypotension, vertigo, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)

• A hemoglobin value <12.5 g/dl (7.8 mmol/l) and/or a hematocrit value <37.9% and/or a Red Blood Cell count <4.08 T/l (4080 mm3)