Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
filibuvir+ Contraceptives · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1. filibuvir + Oral Contraceptives | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| filibuvir + Oral Contraceptives | 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). |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
Filibuvir is an investigational small molecule being developed for the treatment of chronic Hepatitis C, Hepatitis C, and Hepatitis. It is intended for use in patients with these viral liver infections, including those who are treatment naive with genotype 1 HCV.
Filibuvir is a small molecule antiviral agent. Its specific molecular target has not been disclosed in the available information, so its exact mechanism of action is not detailed here.
Filibuvir is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE.
Filibuvir is in Phase 2 clinical development. It has completed one Phase 2 trial and two Phase 1 trials, but it is not approved and remains investigational.
Filibuvir has been studied in three completed trials: NCT00918476, a Phase 1 drug interaction study; NCT00987337, a Phase 2 trial in treatment naive HCV genotype 1 subjects; and NCT01210404, a Phase 1 drug interaction study with methadone.
Filibuvir is also known by the code name PF-00868554. This alternative name is used in some clinical and research contexts to refer to the same investigational drug.