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

NCT01297192 | Completed Phase 1

• 2 other identifiers: 178-CL-0692008-007929-40
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Keywords

YM178; Mirabegron; DDI; Phase I; Solifenacin; Pharmacokinetics; Pharmacokinetics of mirabegron

Outcome Measures

Primary Outcomes (2)

• Assessment of pharmacokinetics of solifenacin through analysis of blood samples

  Days 1 - 9 and Days 23 - 39

• Assessment of pharmacokinetics of mirabegron through analysis of blood samples

  Time Frame: Days 1 - 6 and Days 16 - 21

Study Arms (2)

Treatment Arm 1

OTHER

The effect of mirabegron on the pharmacokinetics of solifenacin

Drug: solifenacin succinate; Drug: mirabegron

Treatment Arm 2

OTHER

The effect of solifenacin on the pharmacokinetics of mirabegron

Drug: solifenacin succinate; Drug: mirabegron

Interventions

solifenacin succinate DRUG

Oral

Also known as: Vesicare, YM905

Treatment Arm 1; Treatment Arm 2

mirabegron DRUG

Oral

Also known as: YM178

Treatment Arm 1; Treatment Arm 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Paris, 75015, France

Location

MeSH Terms

Interventions

Solifenacin Succinate; mirabegron

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Use Central Contact

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 16, 2011
• Study Start: March 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

FR (1)