Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01497327 | Open-Label Hepatic Impairment Study | PHASE1 | COMPLETED | 24 | — | — | Jul 1, 2011 | Jan 1, 2012 | Jun 8, 2012 | 2 | United States, Puerto Rico |
To characterize the pharmacokinetics (PK) of PSI-352938 over 7 days of dosing with PSI-352938 in HCV-infected patients with varying degrees of hepatic impairment compared to historical PK data.
To characterize the PK of PSI-7977 and metabolites over 7 days of dosing with PSI-7977 in HCV-infected patients with varying degrees of hepatic impairment compared to historical PK data.
| Arm | Type | Description |
|---|---|---|
| PSI-352938 Group A | EXPERIMENTAL | Mild (Child-Pugh Class A; 5-6) hepatic impairment |
| PSI-352938 Group B | EXPERIMENTAL | Moderate (Child-Pugh Class B; 7-9) hepatic impairment |
| PSI-352938 Group C | EXPERIMENTAL | Severe (Child-Pugh Class C; 10-15) hepatic impairment |
| PSI-7977 Group A | EXPERIMENTAL | Mild (Child-Pugh Class A; 5-6) hepatic impairment |
| PSI-7977 Group B | EXPERIMENTAL | Moderate (Child-Pugh Class B; 7-9) hepatic impairment |
| PSI-7977 Group C | EXPERIMENTAL | Severe (Child-Pugh Class C; 10-15) hepatic impairment |
| Name | Type | Description |
|---|---|---|
| PSI-352938 | DRUG | PSI-352938 300mg once daily (QD) for seven days |
| PSI-7977 | DRUG | PSI-7977 400mg QD for seven days |
Inclusion Criteria: * Hepatic impaired Males or females of non-childbearing potential aged \> 18 years with Chronic HCV-infection * Naïve to all direct acting anti-viral (DAA) treatments for chronic HCV infection. * Documented Cirrhosis Exclusion Criteria: * Prior PEG/RBV null responders. * Unsta...
| 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 |