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

NCT ID: NCT00918476

Last Updated: 2011-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-02-28

Brief Summary

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.

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.

Conditions

Hepatitis C

Study Design

• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

1. filibuvir + Oral Contraceptives

Group Type: EXPERIMENTAL

filibuvir + Oral Contraceptives

Intervention Type: DRUG

This is an open-label, fixed sequence study to investigate the effect of filibuvir (600 mg BID on the pharmacokinetics of oral contraceptives steroids. Sixteen subjects who have been on any combination of ethinyl estradiol and levonorgesterol oral contraceptives for at least one consecutive month prior to Period 1 will be enrolled into the study. The study will be conducted over two 28 day menstrual cycles and Day 1 of each period is defined as the first day of dosing OC in each cycle. During the first cycle (Period 1), the subjects will receive OC QD for 21 days and filibuvir BID on Days 22 through 28. During the second cycle (Period 2) the subjects will receive OC QD and filibuvir BID for 21 days. The dosing of filibuvir will start in Period 1 (Days 22 - 28).

Interventions

filibuvir + Oral Contraceptives

This is an open-label, fixed sequence study to investigate the effect of filibuvir (600 mg BID on the pharmacokinetics of oral contraceptives steroids. Sixteen subjects who have been on any combination of ethinyl estradiol and levonorgesterol oral contraceptives for at least one consecutive month prior to Period 1 will be enrolled into the study. The study will be conducted over two 28 day menstrual cycles and Day 1 of each period is defined as the first day of dosing OC in each cycle. During the first cycle (Period 1), the subjects will receive OC QD for 21 days and filibuvir BID on Days 22 through 28. During the second cycle (Period 2) the subjects will receive OC QD and filibuvir BID for 21 days. The dosing of filibuvir will start in Period 1 (Days 22 - 28).

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Pfizer, Inc.

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Brussels, , Belgium

Countries

Belgium

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8121008&StudyName=Investigation%20Of%20The%20Effect%20Of%20Steady%20State%20Filibuvir%20On%20The%20Pharmacokinetics%20Of%20Oral%20Contraceptives%20%28Levonorgestrel%20And%20Ethinyl%20Estradiol

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Other Identifiers

A8121008

Identifier Type: -

Identifier Source: org_study_id