| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02173574 | Two-way Interaction Between Alisporivir and EDP239 | PHASE1 | COMPLETED | 42 | — | — | Aug 1, 2014 | Nov 1, 2014 | Jan 9, 2015 | 1 | Germany |
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...