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Clinical Trials/NCT01478503
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

Astellas Pharma Inc2 sites in 1 country96 target enrollmentStarted: May 2005Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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