A Study to Evaluate How Mirabegron Enters and Leaves the Bloodstream According to Age and Sex

NCT01285596 | Completed Phase 1

• 2 other identifiers: 178-CL-0722008-006005-16
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Young and elderly, male and female subjects are each given 2 different doses of mirabegron for 7 days each. Levels of mirabegron in the blood are assessed.

Conditions

Healthy Volunteers; Pharmacokinetics of Mirabegron

Keywords

Pharmacokinetics; Cardiography; Impedance; Age groups; Gender Identity

Outcome Measures

Primary Outcomes (1)

• Assessment of pharmacokinetics of mirabegron and its metabolites

  Days 6 - 14 + Days 21 - 29

Secondary Outcomes (1)

• Impedance cardiography assessed through evaluation of cardiac outputs, stroke volume, systemic vascular resistance index, mean arterial blood pressure and heart rate

  Days -1, 1, 6 and 7

Interventions

Mirabegron DRUG

oral

Also known as: YM178

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy elderly subject aged 55 years or more OR Healthy young subject aged 18 to 45 years, inclusive
• Male 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, OR
• 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: A) Diaphragm with spermicide; B)Intrauterine device; C)Sexual partner is using condoms in combination with a spermicidal creamDuring the study the subject is willing to use 1 of the 3 following contraceptive methods: diaphragm with spermicide, intrauterine device or 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 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 measurements
• Any clinically significant history of asthma, eczema, any other 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 investigator
• Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
• A hemoglobin value \<13 g/dl (8.1 mmol/l) for males or \<12 g/dl (7.5 mmol/l) for females OR a hematocrit value \<40.0% for males or \<37% for females OR a Red Blood Cell count \<4.5 T/l (4500 mm3) for males or \<3.8 T/l (3800 mm3) for females at screening and/or on the day of admission into the clinical unit
• Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse \<40 or \>90 bpm; mean systolic blood pressure \>160 mmHg (elderly) or \>140 mmHg (young); mean diastolic blood pressure \>100 mmHg (elderly) or \>90 mmHg (young), 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 measurements 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, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of 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 drinking more than 21 units of alcohol for males or more than 14 units of alcohol per week for females (1 unit = 270 cc of beer or 40 cc of spirits or 1 glass of wine) within 3 months prior to admission to the Clinical Unit
• Positive test for drugs of abuse or positive alcohol test at screening and/or on the day of admission into 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Paris, 75015, France

Location

Related Publications (1)

• Krauwinkel W, van Dijk J, Schaddelee M, Eltink C, Meijer J, Strabach G, van Marle S, Kerbusch V, van Gelderen M. Pharmacokinetic properties of mirabegron, a beta3-adrenoceptor agonist: results from two phase I, randomized, multiple-dose studies in healthy young and elderly men and women. Clin Ther. 2012 Oct;34(10):2144-60. doi: 10.1016/j.clinthera.2012.09.010.

  PMID: 23063375 BACKGROUND

MeSH Terms

Interventions

mirabegron

Study Officials

• Use Central Contact

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 28, 2011
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

FR (1)