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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01478503
First received: November 21, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted

November 21, 2011
November 21, 2011
May 2005
October 2005   (final data collection date for primary outcome measure)
Pharmacokinetics of mirabegron assessed by plasma concentration [ Time Frame: Pre-dose until 72 hours after dosing ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Double-blind, Randomized, Placebo-controlled, Dose-escalating, Exploratory Study to Investigate the Pharmacokinetics, Safety and Tolerability of Multiple Doses of YM178 OCAS-X in Healthy Young Male and Female Subjects and Healthy Elderly Male and Female Subjects

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.

Each subject will receive a single dose of mirabegron OCAS-X 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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Pharmacokinetics
  • Healthy Subjects
  • Drug: mirabegron OCAS
    oral
    Other Name: YM178 OCAS
  • Drug: Placebo
    oral
  • Experimental: Treatment Arm A
    mirabegron
    Intervention: Drug: mirabegron OCAS
  • Placebo Comparator: Treatment Arm B
    matching placebo
    Intervention: Drug: Placebo
Krauwinkel W, van Dijk J, Schaddelee M, Eltink C, Meijer J, Strabach G, van Marle S, Kerbusch V, van Gelderen M. Pharmacokinetic properties of mirabegron, a β3-adrenoceptor agonist: results from two phase I, randomized, multiple-dose studies in healthy young and elderly men and women. Clin Ther. 2012 Oct;34(10):2144-60. doi: 10.1016/j.clinthera.2012.09.010.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
October 2005
October 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01478503
178-CL-031
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
Astellas Pharma Inc
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP