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GS-9450 · 2 trials · 2 indications
| 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 \>/= ...
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GS-9450 is an investigational small molecule being studied for the treatment of Nonalcoholic Steatohepatitis (NASH) and HCV Infection. It has been evaluated in Phase 2 clinical trials for both conditions, though it is not approved and remains in clinical development.
GS-9450 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company has sponsored clinical trials evaluating the drug in patients with chronic HCV infection and Nonalcoholic Steatohepatitis.
GS-9450 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in patients with chronic HCV infection and another in adults with Nonalcoholic Steatohepatitis. The drug is investigational and has not been approved by regulatory authorities.
GS-9450 has been studied in two completed Phase 2 trials: NCT00725803, which evaluated safety and activity in subjects with chronic HCV infection, and NCT00740610, which assessed safety and activity in adults with Nonalcoholic Steatohepatitis. Both trials are completed.
GS-9450 is a small molecule, but its specific molecular target has not been disclosed in available information. Clinical trials have evaluated its safety, tolerability, pharmacokinetics, and activity in patients with HCV infection and Nonalcoholic Steatohepatitis.