A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01489696
First received: November 21, 2011
Last updated: December 8, 2011
Last verified: December 2011
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Purpose
The study aims to compare blood pressure and pulse in male healthy subjects taking mirabegron and tamsulosin both alone and in combination.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Healthy Subjects Pharmacokinetics |
Drug: mirabegron Drug: tamsulosin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Study to Evaluate Cardiovascular Interactions Between Mirabegron and Tamsulosin |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Cardiovascular interactions assessed by blood pressure and pulse rate [ Time Frame: Pre-dose until 24 hours after dosing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 48 |
| Study Start Date: | August 2010 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment Arm 1
tamsulosin singles doses; mirabegron multiple dose
|
Drug: mirabegron
oral
Other Name: YM178
Drug: tamsulosin
oral
Other Names:
|
|
Experimental: Treatment Arm 2
mirabegron single doses; tamsulosin multiple dose
|
Drug: mirabegron
oral
Other Name: YM178
Drug: tamsulosin
oral
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01489696 History of Changes |
| Other Study ID Numbers: | 178-CL-080, 2010-018690-38 |
| Study First Received: | November 21, 2011 |
| Last Updated: | December 8, 2011 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Astellas Pharma Inc:
|
Pharmacokinetics Mirabegron Tamsulosin Phase 1 |
Additional relevant MeSH terms:
|
Tamsulosin Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013