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

NCT ID: NCT01478529

Last Updated: 2013-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2006-03-31

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.

Conditions

Pharmacokinetics of Mirabegron; Bioavailability; Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Treatment Arm A

low dose of mirabegron

Group Type: EXPERIMENTAL

mirabegron OCAS

Intervention Type: DRUG

oral administration

mirabegron

Intervention Type: DRUG

iv administration

Treatment Arm B

high dose of mirabegron

Group Type: EXPERIMENTAL

mirabegron OCAS

Intervention Type: DRUG

oral administration

mirabegron

Intervention Type: DRUG

iv administration

Interventions

mirabegron OCAS

oral administration

Intervention Type: DRUG

mirabegron

iv administration

Intervention Type: DRUG

Other Intervention Names

YM178 OCAS; YM178

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Study Manager

Role: STUDY_CHAIR

Astellas Pharma Europe B.V.

Locations

Pharma Bio Research

Zuidlaren, , Netherlands

Countries

Netherlands

References

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 beta(3)-adrenoceptor agonist for treatment of overactive bladder. Int J Clin Pharmacol Ther. 2012 Nov;50(11):838-50. doi: 10.5414/CP201782.

Reference Type: BACKGROUND

PMID: 22943933 (View on PubMed)

Other Identifiers

178-CL-033

Identifier Type: -

Identifier Source: org_study_id