| Eligibility |
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.
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