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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478529
• Other study ID #: 178-CL-033
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2011
• Last updated: June 25, 2013
• Start date: February 2006
• Est. completion date: March 2006

Study information

• Verified date: June 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 ß-adrenergic receptor agonists or constituents of the formulations used

• Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 umol/L; ASAT, ALAT or LDH> 2x ULN; ?-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 ß blockers or ß 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bioavailability
• Healthy Subjects
• Pharmacokinetics of Mirabegron

Intervention

Drug:
• mirabegron OCAS
oral administration
• mirabegron
iv administration

Locations

Country	Name	City	State
Netherlands	Pharma Bio Research	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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 ß3-adrenoceptor agonist for treatment of overactive bladder. Int J Clin Pharmacol Ther. 2012 Nov;50(11):838-50. doi: 10.5414/CP201782. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of pharmacokinetics of mirabegron assessed by plasma concentration		Pre-dose until 72 hours after dosing	No
Secondary	Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events		Baseline until 72 hours after dosing	Yes

External Links

•   Link to Results on JAPIC