Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pharmaceutical Research Associates | OTHER |
Not provided
Not provided
Not provided
Not provided
A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP-938 and cyclosporine interaction (Part 1) | Experimental |
| |
| EDP-938 and prednisone interaction (Part 2) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-938 | Drug | Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-938 with and without coadministration with cyclosporine | Up to 12 days | |
| AUC of EDP-938 with and without coadministration with cyclosporine | Up to 12 days | |
| Cmax of EDP-938 with and without coadministration with prednisone | Up to 21 days | |
| AUC of EDP-938 with and without coadministration with prednisone | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events | Up to 21 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Enanta Pharmaceuticals, Inc | Enanta Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc., | Lenexa | Kansas | 66219 | United States |
Not provided
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723099 | EDP-938 |
| D016572 | Cyclosporine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
2-Part Single Group study
Not provided
Not provided
Not provided
Not provided
| EDP-938 | Drug | Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2) |
|
| Cyclosporine | Drug | Subjects will receive one dose of cyclosporine on Day 5 |
|
| Prednisone | Drug | Subjects will receive prednisone once daily from Day 5 to Day 14 |
|
| D014777 | Virus Diseases |
| D007239 | Infections |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |