Study of the Effect of Food on the Pharmacokinetics of Mirabegron

Study Overview
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Brief Summary
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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.

Detailed Description
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Subjects will be assigned in a random order to receive 3 dosing regimens: a single oral dose under a fasting condition; a single oral dose with food (low fat breakfast); a single oral dose with food (high fat breakfast).

Official Title
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A Phase 1, Open-Label, Randomized, Single Oral Dose, Three-Way Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Mirabegron

Conditions
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Healthy, Pharmacokinetics of Mirabegron

Intervention / Treatment
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* Drug: mirabegron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must weigh at least 45 kg and have a body mass index (BMI) between 20.0 and 32.0 kg/m2 , inclusive The subject must have a normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results Female subjects must be post-menopausal (defined as at least 2 years without menses), surgically sterile, or practicing effective contraception, and will continue to use effective contraception during the study period. All females must be non-lactating, and must have a negative pregnancy test result The subject must have negative test results for drugs of abuse and alcohol screens The subject must have good venous access in both arms Exclusion Criteria: The subject has evidence of QTc interval >430 msec for male, >450 msec for female The subject has liver function test values (ALT, AST, or bilirubin) above the upper limit of normal The subject has a history or presence of psychiatric illness, serious active or recurrent infection, or any medical condition or disorder that precludes the subject from participating in the study The subject has 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 The subject has donated or lost ≥ 450 mL blood within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration The subject has received or is anticipated to receive a prescription drug within 14 days prior to Day -1 of Period 1 (within 30 days 1 for any long acting treatments such as depot formulations). Subject has taken any over-the-counter (OTC) medications, including complementary and alternative medicines (except for oral contraceptives and occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week) within 14 days The subject has consumed alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before admission into the unit The subject has used tobacco-containing products and nicotine-containing products within 6 months The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week, or has a history of substance abuse, drug addiction, or alcoholism within past 2 years The subject is known to have hepatitis or HIV-1 and/or HIV-2, or is positive for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: 1. mirabegron, lower dose<br> | Drug: mirabegron<br>* oral tablet<br>* Other names: YM178;|
| Experimental: 2. mirabegron, higher dose<br> | Drug: mirabegron<br>* oral tablet<br>* Other names: YM178;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the effects of food on the pharmacokinetics of a single oral dose of mirabegron |  | 4-5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteer subjects, pharmacokinetics, YM178, mirabegron, food