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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478503
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : July 2, 2013
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Healthy Subjects Drug: mirabegron OCAS Drug: Placebo Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: 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
Study Start Date : May 2005
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Arm Intervention/treatment
Experimental: Treatment Arm A
Drug: mirabegron OCAS
Other Name: YM178 OCAS

Placebo Comparator: Treatment Arm B
matching placebo
Drug: Placebo

Primary Outcome Measures :
  1. Pharmacokinetics of mirabegron assessed by plasma concentration [ Time Frame: Pre-dose until 72 hours after dosing ]

Secondary Outcome Measures :
  1. Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events [ Time Frame: Baseline until 72 hours after dosing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01478503

Kendle Nederland
Utrecht, Netherlands, 358 CJ
Pharma Bio Research
Zuidlaren, Netherlands, 9470 AE
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01478503     History of Changes
Other Study ID Numbers: 178-CL-031
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013

Keywords provided by Astellas Pharma Inc:
Phase 1

Additional relevant MeSH terms:
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents