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Trial record 3 of 47 for:    DESIPRAMINE

To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken Together

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: NCT01478568
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : April 10, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Pharmacokinetics of Mirabegron Healthy Subjects Drug: mirabegron Drug: desipramine Phase 1

Detailed Description:
This is an open-label, one-sequence crossover design study to evaluate the drug-drug interaction between mirabegron and desipramine. The effect of mirabegron on the plasma concentration of desipramine will be evaluated after 13 day repeated administration. The recovery of CYP2D6 activity is also being explored by comparing the pharmacokinetic profiles of desipramine after a 2 week wash-out period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of the CYP2D6 Substrate Desipramine in Healthy Subjects
Study Start Date : October 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: mirabegron / desipramine Drug: mirabegron
Other Name: YM178

Drug: desipramine
Other Names:
  • pertofrane
  • norpramin

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

Secondary Outcome Measures :
  1. Monitoring of safety and tolerability through assessment of vital signs, ECG, clinical safety laboratory and adverse events [ Time Frame: Baseline until End of Study Visit (7 to 14 days after last dose) ]
  2. Pharmacokinetics of desipramine assessed by plasma concentration after wash-out of mirabegron [ Time Frame: Pre-dose until 72 hours after wash-out ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

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): NCT01478568

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SGS Aster
Paris, France, 75015
Sponsors and Collaborators
Astellas Pharma Inc
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Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.

Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT01478568     History of Changes
Other Study ID Numbers: 178-CL-058
2008-000215-15 ( EudraCT Number )
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: July 2013
Keywords provided by Astellas Pharma Inc:
Phase 1
Additional relevant MeSH terms:
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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
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators