Status:
COMPLETED
To Evaluate the Blood and Urine Concentration and the Safety and Tolerability of Increasing Repeated Doses of Mirabegron (YM178) OCAS in Healthy Young and Elderly Males and Healthy Young and Elderly Females
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Pharmacokinetics
Healthy Subjects
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The study aimed to compare age and gender differences for increasing doses of mirabegron when given to healthy young and elderly males and healthy young and elderly females.
Detailed Description
Each subject will receive a single dose of mirabegron OCAS-M or placebo on Day 2, followed by multiple dosing (qd) for 10 days (Day 5-14). Young subjects will be divided into 4 groups and elderly sub...
Eligibility Criteria
Inclusion
- Healthy young subjects aged 18-55 years (inclusive)
- Healthy elderly subjects aged 65-80 years (inclusive)
- Body weight between 60.0 and 100.0 kg (male) or between 50.0 and 90.0 kg (female), and Body Mass Index between 18.0 and 30.0 kg/m2
Exclusion
- Known or suspected hypersensitivity to β-adrenergic receptor agonists or any components of the formulation used
- Any of the liver function tests (i.e. ALT, AST and bilirubin) above the upper limit of normal at repeated measures
- 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, electrocardiogram (ECG) and clinical laboratory tests
- Subjects taking β blockers or β agonists
- Use of any prescribed or Over-the-counter (OTC) 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, rifampicin) in the 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
- Any use of drugs of abuse, or smoking of more than 10 cigarettes (or equivalent) or more than 21 units of alcohol per week within the 3 months prior to study
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01478503
Start Date
May 1 2005
End Date
October 1 2005
Last Update
July 2 2013
Active Locations (2)
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1
Kendle Nederland
Utrecht, Netherlands, 358 CJ
2
Pharma Bio Research
Zuidlaren, Netherlands, 9470 AE