Status:
COMPLETED
A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Pharmacokinetics of Mirabegron
Bioavailability
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief 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.
Detailed 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 mirab...
Eligibility Criteria
Inclusion
- Body weight between 60.0 and 100.0 kg and Body Mass Index between 18.0 and 30.0 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01478529
Start Date
February 1 2006
End Date
March 1 2006
Last Update
June 27 2013
Active Locations (1)
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1
Pharma Bio Research
Zuidlaren, Netherlands, 9470 AE