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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01285596

Collaborator

(none)

Enrollment

Location

Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers Pharmacokinetics of Mirabegron	Drug: Mirabegron	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open-label, Randomized, 2-way Crossover Study to Evaluate the Pharmacokinetics of Mirabegron and Its Metabolites in Healthy Young and Elderly Male and Female Subjects

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Outcome Measures

Primary Outcome Measures

Assessment of pharmacokinetics of mirabegron and its metabolites [Days 6 - 14 + Days 21 - 29]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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
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
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
Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason
Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the study