NCT01478503CompletedPhase 1
Double-blind, Randomized, Placebo-controlled, Dose-escalating, Exploratory Study to Investigate the Pharmacokinetics, Safety and Tolerability of Multiple Doses of YM178 OCAS-M in Healthy Young Male and Female Subjects and Healthy Elderly Male and Female Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 96
- Locations
- 2
- Primary Endpoint
- Pharmacokinetics of mirabegron assessed by plasma concentration
Study Overview
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 subjects into 2 groups. Dosage will be different among groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Treatment Arm A
Experimental
mirabegron
Intervention: mirabegron OCAS (Drug)
Treatment Arm B
Placebo Comparator
matching placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics of mirabegron assessed by plasma concentration
Time Frame: Pre-dose until 72 hours after dosing
Secondary Outcomes
- Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events(Baseline until 72 hours after dosing)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 1
A Study to Evaluate How Mirabegron Enters and Leaves the Bloodstream According to Age and SexHealthy VolunteersPharmacokinetics of MirabegronNCT01285596Astellas Pharma Inc75
Completed
Phase 3
Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive BladderUrinary Bladder, OveractiveNCT00689104Astellas Pharma Inc2,336
Completed
Phase 4
A Phase 4 Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Male Subjects With Overactive Bladder (OAB) Symptoms, While Taking the Alpha Blocker for Benign Prostatic Hypertrophy (BPH)Overactive BladderNCT02656173Astellas Pharma Inc568
Completed
Phase 3
A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.Urologic DiseasesUrinary Bladder, OveractiveUrinary Bladder DiseasesNCT01638000Astellas Pharma Europe Ltd.1,887
Completed
Phase 1
A Study to Evaluate the Possible Effects of Taking Mirabegron While Taking a Contraceptive PillHealthy VolunteersPharmacokinetics of MirabegronNCT01297179Astellas Pharma Inc30