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

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Pharmacokinetics of Mirabegron

Bioavailability

Treatments

Drug: mirabegron OCAS

Drug: mirabegron

Study type

Interventional

Funder types

Industry

Identifiers

NCT01478529

178-CL-033

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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