Approval Probability
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Adjusted LOA
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GS-5816 · 1 trial · 1 indication
The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | (N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816. |
| Cohort 2 | EXPERIMENTAL | (N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816. |
| Name | Type | Description |
|---|---|---|
| GS-5816 | DRUG | - |
Inclusion Criteria: * Diagnosis of chronic (\> 6 months), hepatic impairment. * In the opinion of the Investigator, be in good health. Exclusion Criteria: * Severe hepatic encephalopathy. * Prior placement of a portosystemic shunt. * Hepatorenal or hepatopulmonary syndrome. * Suspicion of hepatoc...
GS-5816 is an investigational small molecule being developed for the treatment of chronic Hepatitis C. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GS-5816 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD.
GS-5816 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval for the treatment of chronic Hepatitis C.
GS-5816 has one completed Phase 1 clinical trial, NCT01817985, which evaluated its pharmacokinetics in subjects with normal hepatic function and moderate or severe hepatic impairment. The trial enrolled 33 participants in the United States and Puerto Rico.
No, GS-5816 is a distinct investigational compound developed by Gilead Sciences. It is not the same as sofosbuvir, which is a different medication used for the treatment of Hepatitis C.