Clinical Trial Details
| Trial ID: | L0161 |
| Source ID: | NCT04480710 |
| Associated Drug: | CRV431 |
| Title: | A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects |
| Acronym: | AMBITION |
| Status: | Completed |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | NASH - Nonalcoholic Steatohepatitis|Fibrosis, Liver|NAFLD - Nonalcoholic Fatty Liver Disease |
| Interventions: | Drug: CRV431 75mg|Drug: Placebo (1 softgel)|Drug: CRV431 225mg|Drug: Placebo (3 softgels) |
| Outcome Measures: | Incidence of safety and tolerability events of CRV431 versus placebo.|Cmax of 75mg and 225mg CRV431 in presumed NASH F2/F3 subjects.|AUC of 75mg and 225mg CRV431 in presumed NASH F2/F3 subjects.|Tmax of 75mg and 225mg CRV431 in presumed NASH F2/F3 subjects.|Tmin of 75mg and 225mg CRV431 in presumed NASH F2/F3 subjects.|t1/2 of 75mg and 225mg CRV431 in presumed NASH F2/F3 subjects.|CL/F of 75mg and 225mg CRV431 in presumed NASH F2/F3 subjects.|Vz/F of 75mg and 225mg CRV431 in presumed NASH F2/F3 subjects.|Percent decrease from baseline to end of study of non-evasive antifibrotic markers. |
| Sponsor/Collaborators: | Hepion Pharmaceuticals, Inc. |
| Gender: | All |
| Age: | 18 Years to 75 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 49 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment |
| Start Date: | June 23, 2020 |
| Completion Date: | October 30, 2021 |
| Results First Posted: | -- |
| Last Update Posted: | January 10, 2022 |
| Locations: | Conquest Clinical Research, Orange, California, United States|Alliance Clinical Research, Poway, California, United States|La Salud Research, Inc., Miami, Florida, United States|Progressive Medical Research, Port Orange, Florida, United States|Covenant Research, LLC., Sarasota, Florida, United States|Gastrointestinal Specialists of Georgia, Marietta, Georgia, United States|Aventiv Research Inc., Columbus, Ohio, United States|Quality Research Inc., San Antonio, Texas, United States|Pinnacle Research Group, San Antonio, Texas, United States|FDI Clinical Research, San Juan, Puerto Rico |
| URL: | https://ClinicalTrials.gov/show/NCT04480710 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D091 | CRV431 | Chemical drug | -- | CyP inhibitor | -- | Under clinical trials | Details |
| D010 | Amoxicillin | Chemical drug | DB01060 | -- | -- | Under clinical trials | Details |
| D223 | Metabolic Cofactor Supplementation | Supplement | -- | -- | -- | Under clinical trials | Details |