A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants
Condition: Pharmacokinetics of Mirabegron; Food Effect; Healthy Chinese Subjects
Intervention: mirabegron
Intervention description: Oral adminstration
Intervention MeSH terms: Mirabegron
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This was a two-way crossover design with 2 period and 2 dose groups. Participants were randomized to 1 of 4 sequences dependent on dose and period assigned.
Masking: None (Open Label)
Masking description: This was an open label study.
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mirabegron; pharmacokinetics; two-way crossover

Summary:

      This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of
      mirabegron in healthy Chinese male and female participants.

      This study also evaluated the safety and tolerability of single oral doses of mirabegron in
      healthy Chinese male and female participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a body mass index range of 19.0 to 24.9 kg/m^2, inclusive and weighs at
             least 50 kg for male subjects and 45 kg for female subjects at screening.

          -  Female subject is not pregnant and at least 1 of the following conditions apply:

               -  Not a woman of childbearing potential (WOCBP)

               -  WOCBP who agrees to follow the contraceptive guidance from the time of informed
                  consent through at least 30 days after final IP administration

          -  Female subject must agree not to breastfeed starting at screening and throughout the
             study period and for 30 days after final IP administration.

          -  Female subject must not donate ova starting at first dose of IP and throughout the
             study period and for 30 days after final IP administration.

          -  Male subject with female partner(s) of childbearing potential (including breastfeeding
             partner[s]) must agree to use contraception throughout the study period and for 30
             days after final IP administration.

          -  Male subject must not donate sperm during the study period and for 30 days after final
             IP administration.

          -  Male subject with pregnant partner(s) must agree to remain abstinent or use a condom
             for the duration of the pregnancy throughout the study period and for 30 days after
             final IP administration.

          -  Subject agrees not to participate in another interventional study while participating
             in the present study, defined as 84 days prior screening until completion of the last
             study visit.

        Exclusion Criteria:

          -  Female subject who has been pregnant within 6 months prior to screening or
             breastfeeding within 3 months prior to screening.

          -  Subject has a known or suspected hypersensitivity to mirabegron or any components of
             the formulation used.

          -  Subject has had previous exposure with mirabegron.

          -  Subject has any of the liver function tests (alkaline phosphatase, alanine
             aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase
             and total bilirubin [TBL]) ≥ 1.5 × upper limit of normal (ULN) on day -1 of period 1.

          -  Subject has any clinically significant history of allergic conditions (including drug
             allergies, asthma, eczema or anaphylactic reactions, but excluding untreated,
             asymptomatic, seasonal allergies) prior to first IP administration.

          -  Subject has any history or evidence of any clinically significant cardiovascular,
             gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic,
             urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major
             disease or malignancy.

          -  Subject has/had febrile illness or symptomatic, viral, bacterial (including upper
             respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day
             -1 of period 1.

          -  Subject has any of the following concerns with regard to tuberculosis:

               -  History of active tuberculosis

               -  Abnormalities detected in a chest X-ray on day -1 of period 1

               -  Contact with infectious tuberculous patients

          -  Subject has any clinically significant abnormality following the physical examination,
             electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or
             on day -1 of period 1.

          -  Participant has a mean pulse < 45 bpm, > 99 bpm; mean body temperature < 35.0°C, >
             37.5°C; mean systolic blood pressure < 90 mmHg, ≥ 140 mmHg; mean diastolic blood
             pressure < 40 mmHg, ≥ 90 mmHg (measurements taken in triplicate after participant has
             been resting in the supine position for at least 5 minutes) at screening or on day-1
             of period 1. If the mean blood pressure exceeds the limits above, 1 additional
             triplicate may be taken.

          -  Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of: ≥
             430 msec (for male subjects) ≥ 450 msec (for female subjects) at screening or on day-1
             of period 1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG
             may be taken.

          -  Subject has used any prescribed or nonprescribed drugs (including vitamins, natural
             and herbal remedies, e.g., St. John's Wort and traditional Chinese medicine) in the 2
             weeks prior to first IP administration, except for occasional use of paracetamol (up
             to 2 g/day), topical dermatological products, including corticosteroid products,
             hormonal contraceptives or hormone replacement therapy (HRT).

          -  Subject has a history of smoking > 10 cigarettes (or equivalent amount of tobacco) per
             day within 3 months prior to day -1 of period 1.

          -  Subject has a history of consuming > 21 units for male subjects or > 14 units for
             female subjects of alcohol per week within 3 months prior to day -1 of period 1 (note:
             1 unit = 10 g pure alcohol, 250 mL of beer [5%], 35 mL of spirits [35%] or 100 mL of
             wine [12%]) or the subject has a history of alcohol-dependency, drug-dependency,
             chemical-dependency, or alcohol or drug abuse within 2 years prior to screening or the
             subject tests positive for alcohol at screening or on day -1 of period 1.

          -  Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines,
             cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 of period 1 or
             the subject tests positive for drugs of abuse (amphetamines, benzodiazepines,
             cannabinoids, cocaine and opiates) at screening or on day -1 of period 1.

          -  Subject has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3
             months prior to day -1 of period 1.

          -  Subject has had significant blood loss, donated ≥ 400 mL of whole blood within 90
             days, ≥ 200 mL of whole blood within 30 days or donated blood components within 14
             days prior to day -1 of period 1 and/or received a transfusion of any blood or blood
             products within 60 days.

          -  Subject has a positive serology test for hepatitis A virus antibodies (immunoglobulin
             M), hepatitis B core antibodies, hepatitis B surface antigen, hepatitis C virus
             antibodies, human immunodeficiency virus or syphilis at screening.

          -  Subject is an employee of Astellas, the study-related contract research organizations
             or the clinical unit.