Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)
Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)
The purpose of this study is to estimate the effect of filibuvir on the pharmacokinetics of
 ethinyloestradiol [EE] and levonorgestrel [LN], to assess the safety and tolerability of 600
 mg BID of filibuvir in healthy women and to investigate the pharmacokinetics of 600 mg BID of
 filibuvir in healthy women.
To investigate the effects of multiple oral doses of filibuvir on the steady state
 pharmacokinetics of oral contraceptive steroids in healthy female subjects.
Inclusion Criteria:

 -  Healthy female subjects between the ages of 18 and 45 years, inclusive (Healthy is
 defined as no clinically relevant abnormalities identified by a detailed medical
 history, full physical examination, including blood pressure and pulse rate
 measurement, 12-lead ECG and clinical laboratory tests).

 -  Subjects must have been on any combination of ethinyl estradiol and levonorgesterol
 oral contraceptives for at least one consecutive month prior to Period 1.

 -  Body Mass Index (BMI) of approximately 17.5 to 30.5 kg/m2; and a total body weight >45
 kg.

 -  Evidence of a personally signed and dated informed consent document indicating that
 the subject (or a legally acceptable representative) has been informed of all
 pertinent aspects of the trial.

 -  Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
 and other trial procedures.

 -  Must be willing to practice an alternative method of contraception for the duration of
 the study in addition to oral contraceptive use.

 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).