ABOUT THIS STUDY
Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
1. Healthy female subjects of non childbearing potential
Female subjects of non childbearing potential must meet at least 1 of the following criteria:
1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
3. Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential and are not eligible for this study.
2. Body mass index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).
Subjects with any of the following characteristics/conditions will not be included in the
1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).
2. History of drug abuse with less than 6 months of abstinence prior to the baseline
3. History of regular alcohol consumption exceeding 7 drinks/week for female subjects (1
drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL]
of hard liquor) within 6 months before screening.
4. Any medical reason which would contraindicate the administration of oral
contraceptives (as per the label) or history of discontinued use of oral
contraceptives due to medical reasons.
5. Subjects with a known immunodeficiency disorder or a first degree relative with a
6. Subjects who have a malignancy or a history of malignancy, with the exception of
adequately treated or excised non metastatic basal cell or squamous cell cancer of the
skin or cervical carcinoma in situ.
7. Any current evidence of untreated active or latent or inadequately treated infection
with Mycobacterium tuberculosis (TB).
8. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
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