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

Phase 1

Completed

• Conditions: Pharmacokinetics of Mirabegron; Bioavailability; Healthy Subjects
• Interventions: Drug: mirabegron OCAS; Drug: mirabegron

• Registration Number: NCT01478529
• Lead Sponsor: Astellas Pharma Inc

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 mirabegron.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-23
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Arm A	mirabegron OCAS	low dose of mirabegron
Treatment Arm B	mirabegron OCAS	high dose of mirabegron
Treatment Arm A	mirabegron	low dose of mirabegron
Treatment Arm B	mirabegron	high dose of mirabegron

Primary Outcome Measures

Name	Time	Method
Assessment of pharmacokinetics of mirabegron assessed by plasma concentration	Pre-dose until 72 hours after dosing

Secondary Outcome Measures

Name	Time	Method
Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events	Baseline until 72 hours after dosing

Trial Locations

Locations (1)

Pharma Bio Research; 🇳🇱 Zuidlaren, Netherlands