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
Pharmacokinetics, Healthy Subjects
A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects
The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with mild and moderate hepatic impairment compared to healthy subjects.
- Conditions
- Pharmacokinetics, Healthy Subjects, Mild and Moderate Hepatic Impairment
- Trial name
- NCT01579461
- Testing
- mirabegron
- Where
- Slovakia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
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.
Pharmacokinetics of Mirabegron, Food Effect
A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants
This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of mirabegron in healthy Chinese male and female participants.
- Conditions
- Pharmacokinetics of Mirabegron, Food Effect, Healthy Chinese Subjects
- Trial name
- NCT04501640
- Testing
- mirabegron
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma China, 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
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.
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
Phase 1, Bioavailability
A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels
This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose combination (FDC) tablets containing solifenacin succinate and mirabegron with the co-administration of single entity tablets (SET), at three…
- Conditions
- Phase 1, Bioavailability, Healthy Subjects
- Trial name
- NCT02010944
- Testing
- solifenacin succinate, mirabegron, mirabegron/solifenacin succinate
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Overactive Bladder (OAB), Pharmacokinetics of Mirabegron
A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
The purpose of this study was to evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB. This study will also evaluated the safety and tolerability of mirabegron in pediatric participants with OAB and…
- Trial name
- Dolphin (NCT04641975)
- Testing
- Mirabegron
- Where
- 15 sites in Belgium, France and 8 more
- Volunteers
- 26 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metabolic Processes
A Study to Assess the Systemic Pharmacokinetics, Metabolism and Excretion Routes of YM178 in Man, After Administration of Radio-labeled YM178
The study aims to assess the routes and the extent of metabolism and excretion of YM178 after a single dose of 14C-radiolabeled YM178 administered as a drinking solution in healthy male volunteers.
- Trial name
- NCT01651312
- Testing
- 14C-labeled YM178
- Where
- Netherlands
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Pharmacokinetics, Healthy Subjects
To Evaluate the Blood and Urine Concentration and the Safety and Tolerability of Increasing Repeated Doses of Mirabegron (YM178) OCAS in Healthy Young and Elderly Males and Healthy Young and Elderly Females
The study aimed to compare age and gender differences for increasing doses of mirabegron when given to healthy young and elderly males and healthy young and elderly females.
- Trial name
- NCT01478503
- Testing
- mirabegron OCAS
- Where
- 2 sites in Netherlands
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
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
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 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
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 Volunteer, Pharmacokinetics of YM178
A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers
The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the pharmacokinetics of YM178 in healthy adult subjects.
- Trial name
- NCT01334905
- Testing
- YM178
- Where
- Taiwan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy Subjects, Pharmacokinetics of YM178
A Study to Assess Pharmacokinetic Interaction of Multiple Dose Ketoconazole on Single Dose YM178 Oral Controlled Absorption System (OCAS) in Healthy Adult Volunteers
The purpose of this study is to assess the pharmacokinetic interaction of multiple-dose ketoconazole on single-dose YM178 OCAS and the safety and tolerability of YM178 OCAS alone and in combination with ketoconazole in healthy…
- Trial name
- NCT01476800
- Testing
- YM178 OCAS, Ketoconazole
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
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 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