NCT01478568

Brief Summary

The study aims to evaluate if blood levels of desipramine change whilst being dosed at the same time with daily mirabegron.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

October 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
2.9 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

April 10, 2014

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

November 21, 2011

Last Update Submit

April 8, 2014

Conditions

Pharmacokinetics of MirabegronHealthy Subjects

Keywords

PharmacokineticsMirabegronPhase 1

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of desipramine assessed by plasma concentration while at steady state levels of mirabegron

    Pre-dose until 72 hours after dosing

Secondary Outcomes (2)

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

    Baseline until End of Study Visit (7 to 14 days after last dose)

  • Pharmacokinetics of desipramine assessed by plasma concentration after wash-out of mirabegron

    Pre-dose until 72 hours after wash-out

Study Arms (1)

mirabegron / desipramine

EXPERIMENTAL
Drug: mirabegronDrug: desipramine

Interventions

mirabegronDRUG

oral

Also known as: YM178
mirabegron / desipramine
desipramineDRUG

oral

Also known as: pertofrane, norpramin
mirabegron / desipramine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index between 18.5 and 30.0 kg/m2 inclusive
  • Subject is genotyped and phenotyped as an extensive metabolizer for CYP2D6

You may not qualify if:

  • Known or suspected hypersensitivity to YM178 or any of the components of the formulation used
  • Known or suspected hypersensitivity to desipramine or any of the components of the formulation used
  • Pregnant or breast feeding within 6 months before screening assessment
  • Any clinical history of major depressive disorder, cardiovascular disease, urinary retention, glaucoma, thyroid disease and/or seizure disorder
  • Any of the liver function tests (i.e. Alanine Aminotransferase (ALT), Asparate Aminotransferase (AST) and Alkaline phosphatase) above the upper limit of normal at repeated measurements
  • Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever)
  • Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
  • Abnormal pulse rate and/or blood pressure measurements at the pre-study visit as follows: pulse rate \<40 or \>90 bpm; mean systolic blood pressure \>140 mmHg; mean diastolic blood pressure \>90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse rate will be measured automatically)
  • A marked baseline prolongation of QT/QTc interval after repeated measurements of \>450 ms, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS Aster

Paris, 75015, France

Location

Related Publications (1)

  • Krauwinkel W, Dickinson J, Schaddelee M, Meijer J, Tretter R, van de Wetering J, Strabach G, van Gelderen M. The effect of mirabegron, a potent and selective beta3-adrenoceptor agonist, on the pharmacokinetics of CYP2D6 substrates desipramine and metoprolol. Eur J Drug Metab Pharmacokinet. 2014 Mar;39(1):43-52. doi: 10.1007/s13318-013-0133-1. Epub 2013 Jun 1.

    PMID: 23728524BACKGROUND

MeSH Terms

Interventions

mirabegronDesipramine

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Clinical Study Manager

    Astellas Pharma Europe B.V.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 23, 2011

Study Start

October 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

April 10, 2014

Record last verified: 2013-07

Locations

FR(1)