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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Intervention: filibuvir + Oral Contraceptives (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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.

Clinical Details

Official title: A Phase 1, Open Label Fixed Sequence Study To Investigate The Effects Of Multiple Oral Doses Of Filibuvir On The Steady State Pharmacokinetics Of Oral Contraceptive Steroids In Healthy Female Subjects

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: AUCtau, Cmax, for LN and EE on Day 21 in Period 1 and Period 2.

Secondary outcome:

LN and EE - Tmax and t1/2 (if data permit) in Period 1 and Period 2. Filibuvir - AUCtau, Cmax, Cmin, and Tmax on Day 28 of Period 1 and Day 21 of Period 2.

Safety (AE, lab, vital, ECG, etc).

Detailed description: To investigate the effects of multiple oral doses of filibuvir on the steady state pharmacokinetics of oral contraceptive steroids in healthy female subjects.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.


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).

Locations and Contacts

Pfizer Investigational Site, Bruxelles 1070, Belgium
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: June 2010
Last updated: April 18, 2011

Page last updated: August 23, 2015

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