5 completed, 1 terminated. 4 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 4 | Completed 4 |
| Phase 2 | 2 | Completed 1, Terminated 1 |
Follow EDP-305: new trials by email Literature Review of EDP-305 trials Research Report on EDP-305
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH EDP-305 1.5 mg, EDP-305 2 mg, Placebo - Non-Alcoholic Steatohepatitis | Phase 2 | Terminated | Enanta Pharmaceuticals, Inc | 98 | 2020-01-27 | 2023-05-19 |
| A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects EDP-305, Oral Contraceptive - NASH - Nonalcoholic Steatohepatitis | Phase 1 | Completed | Enanta Pharmaceuticals, Inc | 43 | 2018-11-27 | 2019-07-24 |
| Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects EDP-305 - NASH - Nonalcoholic Steatohepatitis | Phase 1 | Completed | Enanta Pharmaceuticals, Inc | 8 | 2018-10-05 | 2018-11-21 |
| Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers Fluconazole, Quinidine, EDP-305 - NASH - Nonalcoholic Steatohepatitis | Phase 1 | Completed | Enanta Pharmaceuticals, Inc | 48 | 2018-07-19 | 2018-12-05 |
| A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis EDP-305 1 mg, EDP-305 2.5 mg, Placebo - Primary Biliary Cholangitis | Phase 2 | Completed | Enanta Pharmaceuticals, Inc | 68 | 2017-12-27 | 2021-05-18 |
| Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers. Midazolam, Caffeine, Rosuvastatin - NASH | Phase 1 | Completed | Enanta Pharmaceuticals, Inc | 24 | 2017-05-11 | 2017-08-21 |
Non-alcoholic Fatty Liver Disease (4) · Fatty Liver (1) · Liver Cirrhosis, Biliary (1)
Enanta Pharmaceuticals, Inc (6)
United States (6) · Canada (2) · Germany (2) · United Kingdom (2) · Argentina (1) · Australia (1) · Austria (1) · Belgium (1) · France (1) · Netherlands (1) · Puerto Rico (1) · Spain (1)
2019 (1)