Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DEB025 · 1 trial · 1 indication
The following PK parameters were determined from the plasma concentration time profile of EDP239 and DEB025 using a non-compartmental method: AUCtau: Area under the plasma concentration-time curve from time zero to the end of the dosing interval AUC0-24: Area under the plasma concentration-time curve from time zero to 24 hours AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. AUClast was calculated as the sum of linear trapezoids using non-compartmental analysis. AUCinf: Area under the plasma concentration-time curve from time zero to infinity. AUCinf was calculated by adding AUClast and the value obtained from dividing the last measurable plasma concentration by λz, where λz was determined from automated linear regression of the last three time points with non-zero concentrations in the terminal phase of the log-transformed concentration-time profile
AEs are reviewed on an ongoing basis
Laboratory samples will be assessed for the following: hematology, blood chemistry, and urinalysis
Cmax,ss was directly determined from the raw plasma concentration-time data.
Blood pressure and pulse rate will be assessed for safety.
| Arm | Type | Description |
|---|---|---|
| Open-Label Single Arm Cohort | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| DEB025 | DRUG | - |
| EDP239 | DRUG | - |
Inclusion Criteria: * Male or female subjects 18 to 55 years of age * Body weight at least 50 kg Exclusion Criteria: * Women of child bearing potential * Tobacco use * History or evidence of any inherited bilirubin disease or disorder, including not not necessarily limited to Dubin-Johnson Syndro...
DEB025 is a small molecule being developed for the treatment of Hepatitis C Virus (HCV) infection. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being studied for its potential role in managing this infectious disease, though it is not yet approved for commercial use.
DEB025 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company. The company is conducting clinical research on this drug candidate for Hepatitis C Virus. Enanta Pharmaceuticals is publicly traded under the ticker symbol ENTA on the stock market.
DEB025 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for Hepatitis C Virus, and its Phase 1 trial has been completed, with no active trials currently ongoing.
DEB025 has one completed clinical trial registered under NCT02173574. This Phase 1 study, titled "Two-way Interaction Between Alisporivir and EDP239," enrolled 42 participants and was conducted in Germany. The trial involved healthy volunteers and was not randomized or double-blinded, with no control group.
DEB025 is also known as Alisporivir, as indicated by the clinical trial title. The Phase 1 study NCT02173574 investigated the interaction between Alisporivir and another drug, EDP239. This confirms that DEB025 and Alisporivir refer to the same investigational compound being developed for Hepatitis C Virus.