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A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01478529
First received: November 21, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted

November 21, 2011
November 21, 2011
February 2006
March 2006   (final data collection date for primary outcome measure)
Assessment of 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
 
A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation
A Single Dose, Open Label, Randomized, Two-period Cross Over Study in Healthy Male Subjects to Assess the Absolute Bioavailability of YM178 OCAS-M Formulation

A study to evaluate how much of the active compound of mirabegron comes into the blood circulation when given as a controlled-release pill as compared to given intravenously.

All participants will receive both oral and iv formulations, separated by a washout period. Treatment arm A will receive a lower dose of mirabegron; Treatment arm B will receive a higher dose of mirabegron.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Pharmacokinetics of Mirabegron
  • Bioavailability
  • Healthy Subjects
  • Drug: mirabegron OCAS
    oral administration
    Other Name: YM178 OCAS
  • Drug: mirabegron
    iv administration
    Other Name: YM178
  • Experimental: Treatment Arm A
    low dose of mirabegron
    Interventions:
    • Drug: mirabegron OCAS
    • Drug: mirabegron
  • Experimental: Treatment Arm B
    high dose of mirabegron
    Interventions:
    • Drug: mirabegron OCAS
    • Drug: mirabegron
Eltink C, Lee J, Schaddelee M, Zhang W, Kerbusch V, Meijer J, van Marle S, Grunenberg N, Kowalski D, Drogendijk T, Moy S, Iitsuka H, van Gelderen M, Matsushima H, Sawamoto T. Single dose pharmacokinetics and absolute bioavailability of mirabegron, a β₃-adrenoceptor agonist for treatment of overactive bladder. Int J Clin Pharmacol Ther. 2012 Nov;50(11):838-50. doi: 10.5414/CP201782.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2006
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body weight between 60.0 and 100.0 kg and Body Mass Index between 18.0 and 30.0 kg/m2

Exclusion Criteria:

  • Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used
  • Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 ųmol/L; ASAT, ALAT or LDH> 2x ULN; ɣ-GT > 3x ULN and/or abnormal serum bilirubin
  • Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
  • Subjects taking β blockers or β agonists (eye drops allowed)
  • Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to the first admission to the Research Unit
  • Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, ophthalmologic, renal, hepatic, neurological, dermatological, psychiatric or metabolic
  • Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
  • QTcB interval of > 430 (mean QTcB of two measurements > 430msec)
  • Abnormal pulse rate measurement (<40 or >90 bpm) at the pre-study visit after subject has been resting in supine position for 5 min.

  • Abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 min as follows:

    • Systolic blood pressure <95 or >160 mmHg
    • Diastolic blood pressure <40 or >90 mmHg
  • Positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and a fall of > 20 mmHg in systolic blood pressure after 2 min standing and an increase in pulse rate of ≥ 20 bpm
  • Regular use of any prescribed or OTC drugs except paracetamol up to 3 g/day, in the 4 weeks prior to admission to the Research Unit OR any use of such drugs in the 2 weeks prior to first admission to the Research Unit
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01478529
178-CL-033
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