Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
intraconazole · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | - |
| Part 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| intraconazole | DRUG | Subjects will receive itraconazole once daily from Day 5 through Day18 |
| Rifampin | DRUG | Subjects will receive rifampin once daily from Day 5 through Day 16 |
| EDP 305 | DRUG | Subjects will receive EDP 305 once daily on Day 1 and Day 14 |
Inclusion Criteria: * An informed consent document signed and dated by the subject. * Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. * Female subjects must be of non-childbearing potential. Exclusion Criteria: * Clinically relevant evidence o...
Intraconazole is being studied for use in NASH, or nonalcoholic steatohepatitis, a metabolic condition. It is currently in Phase 1 clinical development as a small molecule therapeutic. The drug is investigational and has not been approved for any use.
Intraconazole is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ENTA. The company is conducting clinical research on the drug for the treatment of NASH, nonalcoholic steatohepatitis.
Intraconazole is in Phase 1 clinical development for NASH, nonalcoholic steatohepatitis. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed.
Intraconazole has one completed Phase 1 clinical trial, NCT03213145, a drug-drug interaction study with EDP-305 and rifampin in healthy volunteers. The trial enrolled 48 participants in the United States and was not randomized or double-blind.
No, intraconazole is not the same as EDP-305. In the clinical trial NCT03213145, intraconazole was studied alongside EDP-305 and rifampin to evaluate drug-drug interactions. EDP-305 is a separate investigational drug developed by the same company, Enanta Pharmaceuticals.