Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GS-6620 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | OTHER | (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 50 mg GS-6620 or placebo QD in the morning with food \[total daily dose (TDD) = 50 mg\] for 5 days |
| Cohort 2 | OTHER | (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 100 mg GS-6620 or placebo QD in the morning with food (TDD = 100 mg) for 5 days |
| Cohort 3 | OTHER | Cohort 3 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 300 mg GS 6620 or placebo QD in the morning with food (TDD = 300 mg) for 5 days |
| Cohort 4 | OTHER | Cohort 4 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 100 mg GS 6620 or placebo QD in the morning without food (TDD = 100 mg) for 5 days |
| Cohort 5 | OTHER | Cohort 5 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 300 mg GS 6620 or placebo QD in the morning without food (TDD = 300 mg) for 5 days |
| Cohort 6 | OTHER | Cohort 6 (N = 10, genotype 2 or genotype 3): (Active drug: 8, Matching Placebo: 2) 900 mg GS 6620 or placebo QD in the morning without food (TDD = 900 mg) for 5 days |
| Cohort 7 | OTHER | Cohort 7 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 450 mg GS 6620 or placebo, administered BID with food (TDD = 900 mg) for 5 days |
| Cohort 9 | OTHER | Cohort 9 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 900 mg GS 6620 or placebo BID in the with food (TDD = 1800 mg) for 5 days |
| Cohort 11 | OTHER | Cohort 11 (N = 10, genotype 1 : (Active drug: 8, Matching Placebo: 2) Up to 450 mg GS-6620 or placebo as an oral solution, BID, 12 hours apart in the fasted state, 2 hours after a meal (up to TDD = up to 900 mg) for 5 days. |
| Name | Type | Description |
|---|---|---|
| GS-6620 | DRUG | GS-6620 tablet, 50 mg QD |
| GS-6620 tablet, 450 mg BID | DRUG | GS-6620 tablet, 450 mg BID |
| GS-6620 tablet | DRUG | GS-6620 tablet, 900mg , BID |
Inclusion Criteria: * Adult subjects (18-60 years of age or up to 64 years of age with approval) * Documented chronic HCV infection to be of at least 6 months duration and plasma HCV RNA ≥ 5 log10 IU/mL at screening. * HCV treatment naïve * Estimated creatinine clearance ≥ 80 mL/min, * QTcF interva...
GS-6620 is an investigational small molecule being studied for the treatment of chronic Hepatitis C. It is intended for patients with chronic Hepatitis C virus infection, and it is currently in Phase 1 clinical development.
GS-6620 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical research to evaluate the drug's safety and antiviral activity in patients with chronic Hepatitis C.
GS-6620 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety, tolerability, and antiviral effects in patients with chronic Hepatitis C.
GS-6620 has one completed Phase 1 clinical trial, identified as NCT01316237. This study evaluated the safety, tolerability, pharmacokinetics, and antiviral activity of GS-6620 in treatment-naive subjects with chronic Hepatitis C virus infection. The trial enrolled 90 participants and was conducted in the United States and Puerto Rico.
GS-6620 is the primary name for this investigational compound. No alternative names have been reported for this drug in the available clinical trial information.