A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously

NCT ID: NCT01297192

Last Updated: 2013-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-07-31

Brief Summary

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.

Conditions

Healthy Volunteers; Pharmacokinetics of Mirabegron

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Treatment Arm 1

The effect of mirabegron on the pharmacokinetics of solifenacin

Group Type: OTHER

solifenacin succinate

Intervention Type: DRUG

Oral

mirabegron

Intervention Type: DRUG

Oral

Treatment Arm 2

The effect of solifenacin on the pharmacokinetics of mirabegron

Group Type: OTHER

solifenacin succinate

Intervention Type: DRUG

Oral

mirabegron

Intervention Type: DRUG

Oral

Interventions

solifenacin succinate

Oral

Intervention Type: DRUG

mirabegron

Oral

Intervention Type: DRUG

Other Intervention Names

Vesicare; YM905; YM178

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

Paris, , France

Countries

France

Other Identifiers

2008-007929-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

178-CL-069

Identifier Type: -

Identifier Source: org_study_id