A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)
Condition: Healthy
Intervention: PF-06650833; Ethinyl estradiol (EE) and levonogestrel (LN)
Intervention description: 400 mg by mouth (PO) Once daily (QD) for 11 days; Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
Intervention MeSH terms: Ethinyl Estradiol; Contraceptive Agents; Contraceptives, Oral; Estradiol
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1, open label, fixed sequence study of the effect of multiple dose
      PF-06650833 on single dose OC PK in healthy female subjects.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet all of the following inclusion criteria to be eligible for enrollment in
        the study:

          1. Healthy female subjects

          2. 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 will be eligible with adequate
             contraceptive usage.

          3. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

        Exclusion Criteria:

        Subjects with any of the following characteristics/conditions will not be included in the
        study:

          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 alcohol abuse or binge drinking and/or any other illicit drug use or
             dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5
             (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule,
             alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1
             ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).

          3. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

          4. Any current evidence of untreated active or latent or inadequately treated infection
             with Mycobacterium tuberculosis (TB).

          5. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
             testing

          6. Benign ethnic (cyclic) neutropenia.