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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00740610 | Safety, Tolerability, Pharmacokinetics and Activity of GS-9450 in Adults With Non-Alcoholic Steatohepatitis (NASH) | PHASE2 | COMPLETED | 124 | — | — | Aug 1, 2008 | Sep 1, 2009 | Feb 4, 2014 | 33 | United States, France |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 22 subjects to receive 1 mg GS-9450 for 4 weeks |
| Cohort 2 | EXPERIMENTAL | 22 subjects to receive 5 mg GS-9450 for 4 weeks |
| Cohort 3 | EXPERIMENTAL | 22 subjects to receive 10 mg GS-9450 for 4 weeks |
| Cohort 4 | EXPERIMENTAL | 22 subjects to receive 40 mg GS-9450 for 4 weeks |
| Cohort 5 | PLACEBO_COMPARATOR | 22 subjects to receive placebo to match GS-9450 for 4 weeks |
| Name | Type | Description |
|---|---|---|
| GS-9450 | DRUG | GS-9450 capsules at a dose of 1, 5, 10, and 40 mg administered orally once daily |
| GS-9450 Placebo | DRUG | Placebo to match GS-9450 administered orally once daily |
Inclusion Criteria: * 18-75 years of age * ALT \> 60 U/L * fatty liver on screening ultrasound * and biopsy-confirmed NASH * platelet count \>/= 75,000/mm3 and adequate hematologic function (absolute neutrophil count \>/= 1,500/mm3, hemoglobin \>/= 11.0 g/dL) * calculated creatinine clearance \>/= ...