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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01316237 | A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection | PHASE1 | COMPLETED | 90 | — | — | Jan 1, 2011 | Jan 1, 2012 | Mar 26, 2012 | 13 | United States, Puerto Rico |
| 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...