- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01297192
A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously
July 25, 2013 updated by: Astellas Pharma Inc
An Open-label, One-sequence, Two-arm Study to Evaluate the Effect of Steady State Concentrations of Mirabegron on the Pharmacokinetics of Solifenacin and to Evaluate the Effect of Steady State Concentrations of Solifenacin on the Pharmacokinetics of Mirabegron in Healthy Young Male and Female Subjects
This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75015
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male subject must agree to sexual abstinence and/or use a highly effective method of birth control from screening until 3 months after last dose of study medication
Female subject must be of non-child bearing potential, i.e. post menopausal, surgically sterilized (e.g. tubal ligation), hysterectomy in medical history, or must practice an adequate non-hormonal contraceptive method to prevent pregnancies. Non-hormonal contraceptive methods are defined as:
- sexual abstinence from 1 month before admission until 3 months after discharge
- subject's sexual partner has been surgically sterilized (since at least 3 months prior to the screening), or
- subject is under two (2) of the following contraceptive methods: I. diaphragm with spermicide II. intrauterine device III. sexual partner is using condoms in combination with a spermicidal cream
- Body Mass Index between 18.5 and 30.0 kg/m2, inclusive
Exclusion Criteria:
- Known or suspected hypersensitivity to mirabegron or any of the components of the formulation used
- Known or suspected hypersensitivity to solifenacin succinate or any of the components of the formulation used
- Pregnant or breast feeding within 6 months before screening assessment.
- Any of the liver function tests (i.e. ALT, AST and Alkaline phosphatase) above the upper limit of normal at repeated measures
- Any clinical significant history of or at risk for urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma
- Any clinically significant history of asthma, eczema, any other clinically significant allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
- Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
- Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
- Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: pulse <40 or >90 bpm; mean systolic blood pressure >140 mmHg; mean diastolic blood pressure >90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
- A marked baseline prolongation of QT/QTc interval after repeated measurement of >450 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT syndrome (LQTS)
- Use of any prescribed or OTC (over-the counter) drugs (including vitamins, oral contraceptives or hormone replacement therapy, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for paracetamol (up to 3 g/day)
- Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit
- Any use of drugs of abuse within 3 months prior to admission to the Clinical Unit
- History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Clinical Unit
- History of drinking more than 21 units of alcohol per week (1 unit=270 cc of beer or 40 cc of spirits or 1 glass of wine) (>14 units of alcohol for female subjects) within 3 months prior to admission to the Clinical Unit
- Donation of blood or blood products within 3 months prior to admission to the Clinical Unit
- Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2
- Subject who, in the opinion of the investigator, is not likely to complete the trial for any reason
- Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life
- Any clinical condition, which, in the opinion of the investigator, would not allow safe completion of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Treatment Arm 1
The effect of mirabegron on the pharmacokinetics of solifenacin
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Oral
Other Names:
Oral
Other Names:
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Other: Treatment Arm 2
The effect of solifenacin on the pharmacokinetics of mirabegron
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Oral
Other Names:
Oral
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of pharmacokinetics of solifenacin through analysis of blood samples
Time Frame: Days 1 - 9 and Days 23 - 39
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Days 1 - 9 and Days 23 - 39
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Assessment of pharmacokinetics of mirabegron through analysis of blood samples
Time Frame: Time Frame: Days 1 - 6 and Days 16 - 21
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Time Frame: Days 1 - 6 and Days 16 - 21
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
February 15, 2011
First Submitted That Met QC Criteria
February 15, 2011
First Posted (Estimate)
February 16, 2011
Study Record Updates
Last Update Posted (Estimate)
July 29, 2013
Last Update Submitted That Met QC Criteria
July 25, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Adrenergic beta-3 Receptor Agonists
- Mirabegron
- Solifenacin Succinate
Other Study ID Numbers
- 178-CL-069
- 2008-007929-40 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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