Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)

Exclusion Criteria

• •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• •Any medical reason which would contraindicate the administration of oral contraceptives (as per label). Including but not limited to history of unexplained vaginal bleeding, current breast cancer, active liver disease, uncontrolled hypertension, history of diabetes with vascular complications, history of venous thrombosis, stroke, ischemic heart disease, history of severe headaches with focal neurologic symptoms.
• •Female subjects of non-childbearing potential who meet the following criteria:
• •Post menopausal, aged between 45-55 who have been amenorrheic for \>2 years and who meet the criteria for serum FSH levels (\>30 IU/L), or
• •Females who have undergone a hysterectomy, or
• •Females who have undergone tubal ligation, or
• •Females who have undergone bilateral oophorectomy.
• •History of discontinued use of oral contraceptives for medical reasons.
• •History of febrile illness within 5 days prior to the first dose.
• •Any condition possibly affecting drug absorption (eg, gastrectomy).