A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

NCT ID: NCT01489696

Last Updated: 2013-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-02-28

Brief Summary

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

Detailed Description

Treatment arm 1 (effect of mirabegron on tamsulosin): Subjects are randomized into one of two sequences.

Subjects receive 2 singles doses of tamsulosin, once in the absence of mirabegron and once in the presence of mirabegron.

24-hour Cardiovascular (CV) profiles are taken at both baseline days and after the single dose of tamsulosin /combination dose in each sequence. Regular blood samples are also taken to check for a potential Pharmacokinetic (PK) interaction.

Treatment arm 2 (effect of tamsulosin on mirabegron): Subjects are randomized into one of two sequences.

Subjects receive 2 singles doses of mirabegron, once in the absence of tamsulosin and once in the presence of tamsulosin.

24-hour CV profiles are taken at both baseline days and after the single dose of mirabegron/combination dose in each sequence. Regular blood samples are also taken to check for a potential PK interaction.

Conditions

Cardiovascular; Healthy Subjects; Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Treatment Arm 1

tamsulosin singles doses; mirabegron multiple dose

Group Type: EXPERIMENTAL

mirabegron

Intervention Type: DRUG

oral

tamsulosin

Intervention Type: DRUG

oral

Treatment Arm 2

mirabegron single doses; tamsulosin multiple dose

Group Type: EXPERIMENTAL

mirabegron

Intervention Type: DRUG

oral

tamsulosin

Intervention Type: DRUG

oral

Interventions

mirabegron

oral

Intervention Type: DRUG

tamsulosin

oral

Intervention Type: DRUG

Other Intervention Names

YM178; Flomax; Harnal; Omnic

Eligibility 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)

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Study Manager

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

Covance CRU Ltd

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

2010-018690-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

178-CL-080

Identifier Type: -

Identifier Source: org_study_id