A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

NCT01489696 | Completed Phase 1

• 2 other identifiers: 178-CL-0802010-018690-38
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular; Healthy Subjects; Pharmacokinetics

Keywords

Pharmacokinetics; Mirabegron; Tamsulosin; Phase 1

Outcome Measures

Primary Outcomes (1)

• Cardiovascular interactions assessed by blood pressure and pulse rate

  Pre-dose until 24 hours after dosing

Secondary Outcomes (2)

• Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events

  Arm 1: From time of combination dose until 4 days after combination dose / Arm 2: From time of combination dose until 8 days after combination dose

• Potential PK interaction of the combination dosing assessed by serial plasma sampling

  Arm 1: From time of combination dose until 4 days after combination dose (10 time points) / Arm 2: From time of combination dose until 8 days after combination dose (14 time points)

Study Arms (2)

Treatment Arm 1

EXPERIMENTAL

tamsulosin singles doses; mirabegron multiple dose

Drug: mirabegron; Drug: tamsulosin

Treatment Arm 2

EXPERIMENTAL

mirabegron single doses; tamsulosin multiple dose

Drug: mirabegron; Drug: tamsulosin

Interventions

mirabegron DRUG

oral

Also known as: YM178

Treatment Arm 1; Treatment Arm 2

tamsulosin DRUG

oral

Also known as: Flomax, Harnal, Omnic

Treatment Arm 1; Treatment Arm 2

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Covance CRU Ltd

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

mirabegron; Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: December 12, 2011
• Study Start: August 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 9, 2013

Record last verified: 2011-12

Locations

GB (1)