A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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A open-label, randomized, crossover study to assess the effect of food on the pharmacokinetics of single dose of YM178 administered under fasted and fed conditions.

Official Title
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A Phase 1, Open-Label, Single Oral Dose Study to Assess the Safety, Pharmacokinetics and Effect of Food on the Pharmacokinetics of Mirabegron (YM178) in Healthy Volunteers

Conditions
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Healthy Volunteer, Pharmacokinetics of YM178

Intervention / Treatment
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* Drug: YM178


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results at the time of Screening Body weigh at least 50 kg in male and 45 kg in female and body mass index (BMI) between 18.5 and 26.9 kg/m2 All women of child bearing potential are required to use adequate contraception consisting of two forms of birth control Exclusion Criteria: Hypersensitivity to YM178 or other beta-3 agonists or any of the constituents of the formulation used Liver function test values above the upper limit of normal A history or presence of psychiatric illness, serious active or recurrent infection A previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years prior to the study Donated or lost ≥ 500 mL blood within 3 months or donated plasma within 2 weeks prior to the study Receiving or being anticipated to receive a prescription drug or OTC medications within 14 days prior to the study Consuming alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before the study A history of substance abuse, drug addiction, or alcoholism within past 2 years prior to the study currently participating in another clinical trial or taking or has been taking an investigational drug at least 60 days

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A group<br>fasted condition then fed condition | Drug: YM178<br>* oral<br>* Other names: mirabegron;|
| Experimental: Part B group<br>fed condition then fasted condition | Drug: YM178<br>* oral<br>* Other names: mirabegron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of YM178 |  | Up to 96 hrs post dose | 
| AUC (area under the curve) of YM178 plasma concentration |  | Up to 96 hrs post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax of YM178 plasma concentration |  | Up to 96 hrs post dose | 
| t1/2 of YM178 plasma concentration |  | Up to 96 hrs post dose | 
| Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam. |  | Up to 96 hrs post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, Urinary incontinence, YM178, mirabegron, Food effect