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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
|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|
- AUCtau, Cmax, for LN and EE on Day 21 in Period 1 and Period 2. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Safety (AE, lab, vital, ECG, etc). [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2010|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
|Experimental: 1. filibuvir + Oral Contraceptives||
Drug: 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).
To investigate the effects of multiple oral doses of filibuvir on the steady state pharmacokinetics of oral contraceptive steroids in healthy female subjects.