Clinical trials: Pharmacokinetics of Mirabegron
Healthy Volunteers, Pharmacokinetics of Mirabegron
A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously
This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.
- Trial name
- NCT01297192
- Testing
- solifenacin succinate, mirabegron
- Where
- France
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Renal Impairment
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.
- Trial name
- NCT00750620
- Testing
- YM178
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Pharmacokinetics of Mirabegron, Bioavailability
A Study to Find Out How Much Mirabegron Gets Into the Body After Dosing With a Tablet Formulation
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
- Trial name
- NCT01478529
- Testing
- mirabegron OCAS, mirabegron
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Subjects, Pharmacokinetics
Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects
The purpose of this study is to evaluate the effect of solifenacin and mirabegron on the concentrations of tamsulosin HCl after combined dosing.
- Conditions
- Healthy Subjects, Pharmacokinetics, Drug-Drug Interaction (DDI)
- Trial name
- NCT02169713
- Testing
- Mirabegron, Solifenacin succinate, Tamsulosin HCl
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Healthy Volunteers, Pharmacokinetics of Mirabegron
A Study to Evaluate the Possible Effects of Taking Mirabegron While Taking a Contraceptive Pill
The objective of this study is to determine the effect of multiple doses of mirabegron on the pharmacokinetics of an oral contraceptive.
- Trial name
- NCT01297179
- Testing
- Mirabegron, Minidril
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Neurogenic Detrusor Overactivity
Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity
The objective of the study was to evaluate the efficacy, safety, tolerability and pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population.
- Trial name
- Crocodile (NCT02751931)
- Testing
- Mirabegron
- Where
- 32 sites in Australia, Belgium and 17 more
- Volunteers
- 91 people
- Sponsor
- Astellas Pharma Europe B.V.
Neurogenic Detrusor Overactivity
A Study to Learn How Effective and Safe the Drug 'Mirabegron' is and How Long it Stays in the Body of Children Aged 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity
People with neurogenic detrusor overactivity (NDO) have poor bladder control because of how their nerves to the bladder are wired. This can cause high pressure in the bladder, causing it to leak urine by accident (incontinence).
- Trial name
- NCT05621616
- Testing
- mirabegron
- Where
- 3 sites in Philippines, Poland
- Volunteers
- 7 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Overactive Bladder, Neurogenic Detrusor Overactivity
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)
The purpose of the study is to evaluate the pharmacokinetics (PK) of mirabegron oral suspension after single dose administration in children with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB).
- Trial name
- NCT02526979
- Testing
- mirabegron
- Where
- 3 sites in Denmark, Poland
- Volunteers
- 9 people
- Sponsor
- Astellas Pharma Europe B.V.
Healthy
A Study to Evaluate the Effect of a Single Dose of Digoxin on the Actions in the Bodies of Healthy Subjects After Having Taken Several Doses of YM178
A study that evaluates the interaction in healthy subjects of the heart drug Digoxin on YM178, when the latter is taken on a continuous basis, in order to establish that there is no risk to patients who may take this combination…
- Trial name
- NCT01663961
- Testing
- YM178 OCAS, Digoxin
- Where
- France
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Pharmacokinetics of Mirabegron, Healthy Subjects
To Compare Blood and Urine Concentrations of Mirabegron (YM178) in Healthy Poor or Extensive Metabolizers for CYP2D6 and to Assess the Effect of Mirabegron on the Metabolism of Metoprolol
The study aims to compare blood and urine concentrations of mirabegron (YM178) in healthy poor or extensive metabolizers for CYP2D6 and to evaluate if blood levels of metoprolol change whilst being dosed at the same time with…
- Trial name
- NCT01478490
- Testing
- mirabegron, metoprolol
- Where
- Netherlands
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Volunteers, Pharmacokinetics of Mirabegron
A Study to Evaluate How Mirabegron Enters and Leaves the Bloodstream According to Age and Sex
Young and elderly, male and female subjects are each given 2 different doses of mirabegron for 7 days each. Levels of mirabegron in the blood are assessed.
- Trial name
- NCT01285596
- Testing
- Mirabegron
- Where
- France
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Subjects, Plasma Concentration of Mirabegron
A Study to Evaluate Absorption, Distribution and Elimination of Mirabegron After Oral Administration to Non-elderly Healthy Chinese Subjects
The purpose of this study is to evaluate safety and absorption, distribution and elimination of mirabegron after oral administration to Chinese subjects.
- Trial name
- NCT01747564
- Testing
- YM178 (mirabegron)
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Volunteer, Pharmacokinetics of YM178
A Study to Investigate the Food Effect on the Pharmacokinetics of YM178 in Healthy, Non-elderly Volunteers
The purpose of the study is to evaluate the effect of food intake on the pharmacokinetics of YM178 in healthy, non-elderly adult subjects.
- Trial name
- NCT00965926
- Testing
- YM178
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Volunteers, Pharmacodynamics of Mirabegron
A Study in Healthy Young Men to Look at What Drives the Cardiovascular Effects After Dosing With Mirabegron.
To explore what is driving heart-rate increases after dosing with mirabegron. Subjects will be given a beta-blocker at the same time as mirabegron.
- Trial name
- NCT01284868
- Testing
- mirabegron, Bisoprolol, propranolol
- Where
- France
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Pharmacokinetics of YM178, Healthy Subjects
A Study to Compare the Actions in the Body of Healthy Subjects of Three Modified Release Formulations of YM178 Under Fasted and Fed Conditions With One Immediate Release Formulation of YM178 Under Fasted Conditions
The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed and eliminated from the body, and how well it is tolerated, when given in three different tablet formulations (sustained release) once a…
- Trial name
- NCT01646294
- Testing
- YM178 modified release (OCAS), YM178 immediate release (IR)
- Where
- Netherlands
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Pharmacokinetics of Mirabegron and Tolterodine, Healthy
Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine
To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects on the pharmacokinetics (PK) of tolterodine and its metabolites. In addition, the safety of these products will be assessed.
- Trial name
- NCT01964183
- Testing
- tolterodine, mirabegron
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Neurogenic Detrusor Overactivity, Overactive Bladder
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
The purpose of this study is to evaluate the pharmacokinetics as well as the safety and tolerability of mirabegron OCAS tablets after single-dose administration at different dose levels in children and adolescents with NDO or OAB.
- Conditions
- Neurogenic Detrusor Overactivity, Overactive Bladder, Pharmacokinetics of Mirabegron
- Trial name
- NCT02211846
- Testing
- Mirabegron
- Where
- 13 sites in Belgium, Denmark and 3 more
- Volunteers
- 34 people
- Sponsor
- Astellas Pharma Inc
Healthy, Pharmacokinetics of Mirabegron
Study of the Effect of Food on the Pharmacokinetics of Mirabegron
The purpose of this study is to assess the effect of food on the pharmacokinetics of a single oral dose of mirabegron in healthy male and female subjects.
- Trial name
- NCT00939757
- Testing
- mirabegron
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Pharmacokinetics of YM178
Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers
The objective of the study is to assess the PK, safety and tolerability of a single dose of mirabegron alone and in combination with repeat doses of rifampin, a potent CYP3A4 inducer.
- Trial name
- NCT00776516
- Testing
- mirabegron, rifampin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Subjects, Pharmacokinetics
Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects
The purpose of this study is to evaluate the effect of steady state solifenacin and mirabegron on the pharmacokinetics of co-administered steady state digoxin.
- Conditions
- Healthy Subjects, Pharmacokinetics, Drug-Drug Interaction (DDI)
- Trial name
- NCT02127034
- Testing
- Mirabegron, Solifenacin, Digoxin
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.