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PSI-352938 · 1 trial · 1 indication
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 |
PSI-352938 is an investigational small molecule being developed for the treatment of Hepatitis C. It is a direct-acting antiviral agent studied in patients with this chronic liver infection. The drug is currently in clinical development and has not been approved by regulatory authorities.
PSI-352938 is a small molecule antiviral that targets the Hepatitis C virus. As a direct-acting antiviral, it is designed to inhibit viral replication. The specific molecular target has not been disclosed in available information, but the drug is being evaluated for its ability to treat Hepatitis C infection.
PSI-352938 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead is known for its work in antiviral therapies, particularly for Hepatitis C and HIV.
PSI-352938 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is still in early-stage testing to evaluate its safety, tolerability, and pharmacokinetics in humans.
PSI-352938 has been studied in one completed Phase 1 clinical trial, identified as NCT01497327. This was an open-label hepatic impairment study conducted in the United States and Puerto Rico, enrolling 24 participants with Hepatitis C. The trial was controlled but not double-blinded.
PSI-352938 is a distinct investigational compound developed by Gilead Sciences. It is not the same as other approved Hepatitis C drugs such as sofosbuvir or ledipasvir. PSI-352938 is a separate molecule that has undergone early-stage clinical testing for Hepatitis C.