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

NCT01478529 | Completed Phase 1

• 1 other identifier: 178-CL-033
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics of Mirabegron; Bioavailability; Healthy Subjects

Keywords

Pharmacokinetics; Mirabegron; Phase 1

Outcome Measures

Primary Outcomes (1)

• Assessment of pharmacokinetics of mirabegron assessed by plasma concentration

  Pre-dose until 72 hours after dosing

Secondary Outcomes (1)

• Monitoring of safety and tolerability through assessment of vital signs, Electrocardiogram (ECG), clinical safety laboratory and adverse events

  Baseline until 72 hours after dosing

Study Arms (2)

Treatment Arm A

EXPERIMENTAL

low dose of mirabegron

Drug: mirabegron OCAS; Drug: mirabegron

Treatment Arm B

EXPERIMENTAL

high dose of mirabegron

Drug: mirabegron OCAS; Drug: mirabegron

Interventions

mirabegron OCAS DRUG

oral administration

Also known as: YM178 OCAS

Treatment Arm A; Treatment Arm B

mirabegron DRUG

iv administration

Also known as: YM178

Treatment Arm A; Treatment Arm B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight between 60.0 and 100.0 kg and Body Mass Index between 18.0 and 30.0 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Pharma Bio Research

Zuidlaren, 9470 AE, Netherlands

Location

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

  PMID: 22943933 BACKGROUND

MeSH Terms

Interventions

mirabegron

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe B.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: February 1, 2006
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

NL (1)