NCT01478503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

5 months

First QC Date

November 21, 2011

Last Update Submit

July 1, 2013

Conditions

PharmacokineticsHealthy Subjects

Keywords

PharmacokineticsMirabegronPhase 1Dose-Escalation

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of mirabegron assessed by plasma concentration

    Pre-dose until 72 hours after dosing

Secondary Outcomes (1)

  • Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events

    Baseline until 72 hours after dosing

Study Arms (2)

Treatment Arm A

EXPERIMENTAL

mirabegron

Drug: mirabegron OCAS

Treatment Arm B

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

Interventions

mirabegron OCASDRUG

oral

Also known as: YM178 OCAS
Treatment Arm A
PlaceboDRUG

oral

Treatment Arm B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kendle Nederland

Utrecht, 358 CJ, Netherlands

Location

Pharma Bio Research

Zuidlaren, 9470 AE, Netherlands

Location

Related Publications (1)

  • 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 beta3-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.

    PMID: 23063375BACKGROUND

Study Officials

  • Clinical Study Manager

    Astellas Pharma Europe B.V.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 23, 2011

Study Start

May 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

NL(2)