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filibuvir + Contraceptives

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Apr 19, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00918476Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)PHASE1 COMPLETED 14Jun 1, 2010Feb 1, 2011Apr 19, 20111 Belgium
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Study Endpoints
Primary Endpoints
AUCtau, Cmax, for LN and EE on Day 21 in Period 1 and Period 2.
21 days
Secondary Endpoints
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.
21 days
Safety (AE, lab, vital, ECG, etc).
21 days
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Study Design & Arms
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
1. filibuvir + Oral ContraceptivesEXPERIMENTAL -
Interventions
NameTypeDescription
filibuvir + Oral ContraceptivesDRUGThis 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).
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Eligibility Criteria
Age Range18 Years — 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:Belgium
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Competitive Landscape -Hepatitis C 11 trials