A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01489696
First received: November 21, 2011
Last updated: December 6, 2013
Last verified: December 2011

November 21, 2011
December 6, 2013
August 2010
February 2011   (final data collection date for primary outcome measure)
Cardiovascular interactions assessed by blood pressure and pulse rate [ Time Frame: Pre-dose until 24 hours after dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01489696 on ClinicalTrials.gov Archive Site
  • Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Potential PK interaction of the combination dosing assessed by serial plasma sampling [ Time Frame: 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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin
A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Cardiovascular
  • Healthy Subjects
  • Pharmacokinetics
  • Drug: mirabegron
    oral
    Other Name: YM178
  • Drug: tamsulosin
    oral
    Other Names:
    • Flomax
    • Harnal
    • Omnic
  • Experimental: Treatment Arm 1
    tamsulosin singles doses; mirabegron multiple dose
    Interventions:
    • Drug: mirabegron
    • Drug: tamsulosin
  • Experimental: Treatment Arm 2
    mirabegron single doses; tamsulosin multiple dose
    Interventions:
    • Drug: mirabegron
    • Drug: tamsulosin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
February 2011
February 2011   (final data collection date for primary outcome measure)

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)
Male
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01489696
178-CL-080, 2010-018690-38
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
Astellas Pharma Inc
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP