Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–55
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
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;
You may not be if
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 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 drug abuse with less than 6 months of abstinence prior to the baseline visit.
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 hereditary immunodeficiency.
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 testing
Clareo Health | A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)
